Total 14 Director/C-Level Quality Assurance / Control job vacancies in US - California - Thousand Oaks - Field/Remote

• Implements and sustains a comprehensive quality assurance and patient safety programs.
• Leads, develops and manages strategies for measurement aligned with external and internal benchmarks and standards of quality, patient safety, patient experience and risk management.
• Aligns activities, policies, process guidance and analysis (measurement, review, examination) with accreditation standards for quality, patient safety, patient experience, and risk management defined by TJC and AAAHC and industry recognized best practices from reputable sources.
• Develops work plans and performance evaluation criteria; ensures subordinates achieve Agency goals. Provides management direction and leadership under the general direction of the Office Director. Provides leadership, guidance, and direction for the IHS programs supporting and ensuring quality assurance, compliance, patient safety, and risk management. Formulates budget requests and develops related supporting justification narratives to meet program objectives of ensuring consistently high quality in all IHS clinical operations.
• Plans work to be accomplished by subordinates, set and adjust short-term priorities, and prepare schedules for completion of work; Assigns work to subordinates based on priorities, selective consideration of the difficulty and requirements of assignments, and the capabilities of employees; Evaluate work performance of subordinates; Gives advice, counsel, or instruction to employees, and refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Interviews candidates for positions in the unit; recommends appointment, promotion, or reassignment; Hears and resolves complaints from employees, refers group grievances and more serious unresolved complaints to a higher-level supervisor or manager; Effects minor disciplinary measure of warnings and reprimands, and recommends other action in more serious cases; Identifies
  developmental and training needs of employees, provides or arranges for needed development and training; Finds ways to improve

Salary - Competitive + Veolia Benefits (Car Allowance + Significant Bonus & Generous Pension Scheme)
Location - Based close to central motorway links and hybrid working offered. Travel to Veolia offices as requested

When you see the world as we do, you see the chance to help the world take better care of its resources, and help it become a better place for everyone. It's why we're looking for someone who's just as committed as we are, to push for genuine change and bring our ambition of Ecological Transformation to life.

We know that everyone here at Veolia can help us work alongside our communities, look after the environment, and contribute to our inclusive culture.

What we can offer you:

- 25 days of annual leave
- Access to our company pension scheme
- Discounts on everything from groceries to well known retailers
- Access to a range of resources to support your physical, mental and financial health; so you can lean on us whenever you need to
- One paid days leave every year to volunteer and support your community
- Ongoing training and development opportunities, allowing you to reach your full potential

What you'll be doing:

As a senior leader, you'll be accountable for the Risk & Assurance areas of activity within our Commercial and Treatment business functions. These areas include Quality, Health & Safety, Environment, Security, Risk and Insurance.

In this role, you'll need to demonstrate credibility as a trusted leader, capable of negotiating and influencing at the most senior levels of a business. You'll need to have up-to-date knowledge of health and safety matters and a proven track record of designing, creating, implementing, and measuring strategies.

We're looking for a dynamic leader who can build positive relationships, make decisive actions, and work collaboratively with others. If you're someone who values all views and opinions, and isn't afraid to challenge the norm, we want to hear from you.

To embed into these business functions, ensuring strategies are developed and implemented to tackle key problem areas and review trends to develop solutions using an insights-led approach, developing complex business cases to enact change with the ability to present and translate them for relevant audiences.

You will promote a positive and proactive safety culture within their operational business areas ensuring a proactive approach, providing performance analysis, assurance and solutions to the respective Senior Leadership Teams.

What we're looking for:

• Strong planning and organisation with the ability to deliver strong results in a demanding and sometimes priority conflicting environment.
• Demonstrates credibility as a trusted leader and able to negotiate and influence at the most senior levels of a business.
• Evidence of designing, creating, implementing and measuring short, medium and long term Strategies.
• Excellent communication and interpersonal skills are a must, as you'll be nurturing and building long-lasting relationships with internal and external stakeholders. You'll also be expected to create networks with key stakeholders and show evidence of continuous professional development.
• Essential qualifications and skills include a NEBOSH Diploma & Lead Auditor, Level 7 Leadership & Management (or equivalent). It would be desirable if you also have a Quality Diploma & IEMA Environmental Management.

What's next?

Apply today, so we can make a difference for generations to come.

We're proud to be listed in The Sunday Times Best Places to Work 2023, being named as a Top 10 Very Big Organisation and Highly Commended as a workplace for 55+.

This accolade further demonstrates our commitment to our people and our actions in creating an environment where everyone can be their true selves and enjoy working at Veolia.

We want to ensure that you feel supported throughout the application process and provide reasonable adjustments where necessary and requested. If you require any reasonable adjustments as part of your application and interview process please do not hesitate to let us know.

What's next?

Apply today, so we can make a difference for generations to come.

We're proud to be listed in The Sunday Times Best Places to Work 2024, being named as a Top 10 Very Big Organisation to work for two years in a row! This accolade further demonstrates our commitment to our people and our actions in creating an environment where everyone can be their true selves and enjoy working at Veolia.

We want to ensure that you feel supported throughout the application process and provide reasonable adjustments where necessary and requested. If you require any reasonable adjustments as part of your application and interview process please do not hesitate to let us know.

We know how important it is to be fully committed to building and maintaining a diverse and inclusive place to work for every one of our colleagues. We are committed to ensuring that all job applicants and members of staff are treated equally, without discrimination because of sex, gender, sexual orientation, marital or civil partner status, pregnancy or maternity, gender reassignment, race, nationality, ethnic or national origin, religion or belief, disability or age.

We therefore welcome and encourage all candidates who meet the minimum requirements to apply.

Salary - Competitive + Veolia Benefits (Car Allowance + Significant Bonus & Generous Pension Scheme)
Location - Based close to central motorway links and hybrid working offered. Travel to Veolia offices as requested

When you see the world as we do, you see the chance to help the world take better care of its resources, and help it become a better place for everyone. It's why we're looking for someone who's just as committed as we are, to push for genuine change and bring our ambition of Ecological Transformation to life.

We know that everyone here at Veolia can help us work alongside our communities, look after the environment, and contribute to our inclusive culture.

What we can offer you:

- 25 days of annual leave
- Access to our company pension scheme
- Discounts on everything from groceries to well known retailers
- Access to a range of resources to support your physical, mental and financial health; so you can lean on us whenever you need to
- One paid days leave every year to volunteer and support your community
- Ongoing training and development opportunities, allowing you to reach your full potential


What you'll be doing:

As a senior leader, you'll be accountable for the Risk & Assurance areas of activity within our Commercial and Municipal business functions. These areas include Quality, Health & Safety, Environment, Security, Risk and Insurance.

In this role, you'll need to demonstrate credibility as a trusted leader, capable of negotiating and influencing at the most senior levels of a business. You'll need to have up-to-date knowledge of health and safety matters and a proven track record of designing, creating, implementing, and measuring strategies.

We're looking for a dynamic leader who can build positive relationships, make decisive actions, and work collaboratively with others. If you're someone who values all views and opinions, and isn't afraid to challenge the norm, we want to hear from you.

To embed into these business functions, ensuring strategies are developed and implemented to tackle key problem areas and review trends to develop solutions using an insights-led approach, developing complex business cases to enact change with the ability to present and translate them for relevant audiences.

You will promote a positive and proactive safety culture within their operational business areas ensuring a proactive approach, providing performance analysis, assurance and solutions to the respective Senior Leadership Teams.

What we're looking for:

• Strong planning and organisation with the ability to deliver strong results in a demanding and sometimes priority conflicting environment.
• Demonstrates credibility as a trusted leader and able to negotiate and influence at the most senior levels of a business.
• Evidence of designing, creating, implementing and measuring short, medium and long term Strategies.
• Excellent communication and interpersonal skills are a must, as you'll be nurturing and building long-lasting relationships with internal and external stakeholders. You'll also be expected to create networks with key stakeholders and show evidence of continuous professional development.
• Essential qualifications and skills include a NEBOSH Diploma & Lead Auditor, Level 7 Leadership & Management (or equivalent). It would be desirable if you also have a Quality Diploma & IEMA Environmental Management.

What's next?

Apply today, so we can make a difference for generations to come.

We're proud to be listed in The Sunday Times Best Places to Work 2023, being named as a Top 10 Very Big Organisation and Highly Commended as a workplace for 55+.

This accolade further demonstrates our commitment to our people and our actions in creating an environment where everyone can be their true selves and enjoy working at Veolia.

We want to ensure that you feel supported throughout the application process and provide reasonable adjustments where necessary and requested. If you require any reasonable adjustments as part of your application and interview process please do not hesitate to let us know.

What's next?

Apply today, so we can make a difference for generations to come.

We're proud to be listed in The Sunday Times Best Places to Work 2024, being named as a Top 10 Very Big Organisation to work for two years in a row! This accolade further demonstrates our commitment to our people and our actions in creating an environment where everyone can be their true selves and enjoy working at Veolia.

We want to ensure that you feel supported throughout the application process and provide reasonable adjustments where necessary and requested. If you require any reasonable adjustments as part of your application and interview process please do not hesitate to let us know.

We know how important it is to be fully committed to building and maintaining a diverse and inclusive place to work for every one of our colleagues. We are committed to ensuring that all job applicants and members of staff are treated equally, without discrimination because of sex, gender, sexual orientation, marital or civil partner status, pregnancy or maternity, gender reassignment, race, nationality, ethnic or national origin, religion or belief, disability or age.

We therefore welcome and encourage all candidates who meet the minimum requirements to apply.

Your new company
Hays have been exclusively retained by an extremely well-funded biotech driving breakthrough innovations in the space of gene therapy.They have developed an innovative new technology that allows them to deliver gene therapies in a novel way to patients with rare diseases and are currently going into their initial clinical trial to validate its use. Alongside this they have multiple other programmes approaching the clinic and several more in development, giving them a very strong pipeline.The company prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record.
They are looking to add a Director / Senior Director of Process and Compliance to help them move the company's Clinical Technologies forward and are offering an excellent package plus significant remote working flexibility and the chance to make a real impact.


Your new role
This is a permanent position, working closely with the CEO, VP Biometrics and other senior stakeholders to ensure clinical (and potentially other, earlier discovery) technologies remain compliant with regulatory requirements as well as driving innovation within this space, eg through the adoption of new processes/technologies/software, etc.The company is ideally looking for candidates to spend some time in office, but the exact amount is open for discussion dependent on candidate location and other factors.
Major responsibilities will include a mix of (but aren't limited to):

• Establish the implementation roadmap for all clinical technologies that enable clinical trial management and data collection mechanisms
• Develop, manage and implement processes for clinical technology adoption and management, eg software solutions
• Drive new technology solutions for site visits, clinical monitoring, risk management and provide clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients in our studies
• Oversee / manage projects to integrate and implement new technologies within clinical data capture or similar
• Manage the creation of new - and optimisation of existing - quality management processes
• Liaise with colleagues, eg within IT, Clinical Operations, Biometrics, QA & Regulatory Affairs, to ensure clinical trial activities are properly integrated / aligned to protocols
• Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and data capture processes across multiple clinical technology programmes
• Act as a technical expert and leader within the business
• Drive best practice within the business

What you'll need to succeed
As well as strong communication skills for dealing with collaborators, stakeholders and vendors/CROs, you should have:

• A BSc (or equivalent experience) in a discipline such as computer science, biometrics, statistics, IT, or a life sciences discipline such as chemistry, biochemistry or biology
• Experience of the clinical drug development environment including experience in clinical software development and application deployment is essential, whether from a QA/CSV standpoint, or the data management/clinical operations side
• Deep expertise of regulatory requirements and industry standards relevant to clinical research, ensuring compliance throughout all stages of clinical trials
• Proven ability to design and/or develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies

Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes

• Well-versed in the utilisation of common tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etc
• The ability to manage multiple concurrent projects and effectively prioritise between competing requirements

Experience of rare disease / small cohort trials would be an advantage, but is not necessary for this role.


What you'll get in return
You'll get the chance to make a significant impact on the company's clinical development and R&D/discovery projects, taking on project leadership for a number of different aspects, driving the adoption of new protocols and processes to make their operations as innovative and effective as possible whilst maintaining compliance with regulatory standards.The company are very flexible on salary bands and package depending on the skills of the person coming in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership.


What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call me on 0203 465 0057.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career, especially as there are a number of other bioinformatics, data science and statistics positions available.

Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations

The Director of Compliance will be responsible for oversight of all quality assurance operations related to the ORR Call Center and execution of project deliverables. The position will act as a member of the leadership team to recommend technological solutions to building awareness, knowledge, and skill; project manage training and reporting deliverables, and will report to the Project Director for the Call Center. 

Key Responsibilities:  

• Oversee and manage the following: 
• Design and operate quality control measures for call center and program oversight.  
• Ensure accuracy and timeliness in execution of all training, QA, and reporting project deliverables.  
• Provide direct oversight of all work streams related to training, QA, and reporting project deliverables. 
• Work closely with the call center staff, ORR (client) and client’s stakeholders in the execution of deliverables and services.  
• Ensure timely and accurate communication with client to ensure transparency and communication of medium and long-term project activities, outstanding issues, and risk mitigation. 
• Enforce uniform development and quality standards and ensure accuracy of project deliverables. 
• Develop monthly reports using available data 
• Directly supervise all subject matter experts in the development of training, FRA/SWB Supervisor and the QA Manager 
• Analyze data collection instruments, tools, and systems to ensure effectiveness and determine when necessary to update or expand systems to provide robust data to the client.  
• Work with clients and SMEs to perform needs assessments to identify critical knowledge, skills, and behaviors; produce gap analyses; and recommend appropriate learning strategies for call center employees 
• Assure all annual and monthly reports are of high quality and delivered according to contract deliverable schedule 

Basic Qualifications:  

• Masters in social services: a Bachelor’s in the same field can be substituted for the MS/MA if accompanied by a minimum of 8 years of training development work in the field of refugee resettlement 
• 3-5 years managing projects or equivalent of project management such as managing multiple aspects of deliverables, deadlines, and partner relationships  
• Minimum of 5 years experience in determining quality of services 
• Minimum of 5 years experience working with a federal client relationship  
• Active Tier 2 security clearance per contract requirements

Preferred Skills/Experience:  

• Experience conducting detailed training and/or job/task analyses  
• Experience developing both soft-skills and technical training  
• Experience with Office of Refugee Resettlement 
• Experience in a Quality Assurance or Continuous Quality Assurance position 
• Experience interacting with and advising clients  

Professional Skills:  

• Strong project management skills 
• Strong oral and written communication skills  
• Strong analytical, problem-solving, and decision making capabilities  
• Strong attention to detail  
• Ability to multi-task in a fast-paced environment  
• Ability to work well both individually and in a team environment  
• Ability to prioritize multiple tasks while demonstrating the initiative to complete projects with minimum supervision  
• Ability to work with all levels of internal staff, as well as outside clients and vendors  
• Ability to be flexible to handle multiple priorities and to work limited overtime as necessary  
• Ability to travel up to 25%  
• Proficiency in MS Office Applications (Word, PowerPoint, Outlook, Excel, Project) and MS SharePoint  

ICF offers an excellent benefits package, an award-winning talent development program, and fosters a highly skilled, energized and empowered workforce. 

Working at ICF

We can only solve the world's toughest challenges by building an inclusive workplace that allows everyone to thrive. We are an equal opportunity employer, committed to hiring regardless of any protected characteristic, such as race, ethnicity, national origin, color, sex, gender identity/expression, sexual orientation, religion, age, disability status, or military/veteran status. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO & AA policy.

Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation please email icfcareercenter@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.

Read more about workplace discrimination rights, the Pay Transparency Statement, or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act.

Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position is:

Non-CA Pay Range (Annual):

At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company’s incentive plans, the Company’s financial performance, and/or individual employee job performance.

Infinera also offers paid leave, medical, 

dental, and vision coverage, 401(k), life, and disability insurance and to

eligible employees.

The R&D Quality Director role requires a unique blend of management and hands-on expertise, serving as a vital bridge between Quality and R&D. We are seeking a seasoned professional with over 20 years of industry experience, including substantial exposure to both software and hardware development. The successful candidate will lead a team of three quality managers, closely partnering with R&D to drive continuous improvements in product quality and processes. This pivotal role ensures that quality remains at the forefront of R&D efforts, fostering excellence across the entire organization.

Key Tasks & Responsibilities:

Secure Quality in Products & R&D Programs

• Q target setting and monitoring
• Process tailoring to secure programs have optimum R&D processes in place and adequately supported and deployed
• Installation & execution of Program Quality Plans and use of metrics for monitoring and analysis of process performance
• Q-Gate readiness check; product quality reviews and audits to monitor and foster process adherence

Support R&D Process Management

• Support process management with subject matter expertise on international Q standards (e.g. TL, ISO) and best practices (e.g. left shifting)
• Support the development, assessment and implementation of key R&D product and process performance measures/metrics

Drive Continual Improvement

• Promote proactive key improvement quality practices
• Support product RCA analysis on field issues escalated to R&D
• Manage process improvement projects that are aligned with strategic goals
• Provide training as it relates to driving process improvements

Value add:

• Independent and neutral Q org to secure quality in products and R&D programs
• Seamless e2e Q workflow supported via Global Quality organization

KPIs:

• Customer-perceived KPIs (CFD, Outages…)
• Q KPIs (test execution rate, test pass rate, critical faults…)
• R&D KPIs (code coverage, defect density, code review effectiveness…)
• TL9K Metrics for certified Product Categories

Key interfaces:

• R&D / ProdM / Service Teams
• Global Q Community

Required Experience:

• 15+ years of experience in SW & HW Development
• Proven Q mgmt. approach with expertise on best in class Q practices & methods
• Experienced leadership re cross-functional / international teams
• Certified auditor
• ISO9K, TL9k, CMMI & Agile
• Jira, SFDC

#LI-DW

#LI-Hybrid

Infinera is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Infinera complies with all applicable state and local laws governing nondiscrimination in employment.

This is a key role within the Global Quality function, driving a high-performance culture and setting the standard for Quality Excellence. We are seeking a transformative thinker and diligent executor to help improve the operational execution of Complaints & Post Market Surveillance.

The Senior Director, Quality (Complaint Handling/PMS) will be accountable for the global complaint handling and post market surveillance process for the entire business, inclusive of all business units.  You will partner with the business for timely execution of complaint investigations to enable robust feedback from our customers.  You will develop and lead a team that reviews, processes and analyzes complaints data into practical business terms to ensure proper prioritization of initiatives to improve the customer experience and deliver on our forever caring promise.  This strategic partner will collaborate with the commercial organization to ensure all channels for reporting complaints are efficient and integrated, providing them with real-time complaints progress & feedback. 

Your Accountabilities and Responsibilities:

• Define global strategy for complaint handling and post market surveillance across Convatec. 
• Turn complex complaints data/information into practical analytics to facilitate business decisions. 
• Lead, mentor, coach, and develop complaint handling and post market surveillance teams.
• Partner with business unit (BU) leaders with an emphasis in manufacturing site collaboration in BU specific complaint analysis, ensuring the right focus/actions are placed in the main areas of opportunity/concern.
• Establish clear roles & responsibilities when liaising with legal, medical, quality, regulatory, operations, engineering, and other functions in the complaint handling and post market surveillance processes.
• Own  dashboard of performance related to complaint handling and post market surveillance activities.
• Develop strategy that drives improvements in the customer experience and facilitates how customer complaints are collected throughout the world.
• Harmonize & connects global processes for efficiency.
• Define strategy with commercial on how we gather & analyze feedback from social platforms and other media streams.
• Acts as the main point of contact for complaint handling - including complaint processing, investigation, and timely closure.
• Integrate data analytics into established power BI dashboards to enable one source of truth.
• Partner with R&D (Technology & Innovation) to ensure design related complaints have a clear funnel for investigations. 
• Integrate technology into repetitive tasks, to optimize speed of processing and focus on clarity of analytics for signals & corresponding actions.
• Drive continuous improvement in corresponding processes & tools.
• Identify, hire, train, develop and maintain qualified Quality personnel to support the Quality plans, objectives and goals.

The Ideal Candidate should bring the following qualities to the role:

• Minimum of B.S., or equivalent, in a scientific/technical discipline is required.  Advanced degree (M.S., M.B.A, Ph.D. or equivalent) preferred.
• Experience working in an international environment in a global position is required.
• Certifications in Quality Management Systems preferred.
• (5-7) years in the medical device and/or pharmaceutical industry.
• Five to seven (5-7) years’ experience in a leadership role.
• Practical experience and global mastery in global quality standards and regulations governing medical products.
• Outstanding communication skills (both written and spoken), to all layers of the organization, including executive level.
• Emotional Intelligence/cultural awareness (interacting globally).
• Ability to think in a clear, decisive manner, remaining calm under stressful and challenging conditions.
• Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
• Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
• Strong understanding of risk management principles and ability to apply these principles in day-to-day quality management activities, compliance issues, and business challenges.
• Commercially astute and customer focused.

Working Conditions:

• Fulltime position

Travel:

• Role is remote-based with preference to location in the United Kingdom
• Travel is expected to be approximately 25% with projected international travel

Language Skills Required:

• Speaking: English
• Writing/Reading:  English

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen too.  It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.

This is stepping up to a challenge.

This is work that’ll move you.

#ForeverCaring #ForeverConvatec #WeAreConvatec

#LI-DB1

#LI-REMOTE

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com.

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!

Position Overview

In this role, you will implement strategies and operational improvements for the Volume businesses of Global License Compliance (GLC). Your responsibilities will include coaching the GLC sales personnel, managing third-party organizations, and ensuring the efficient operation of the North American business.

Reporting to the Senior Director of GLC, AMER, you will also develop business processes and strategies to exceed Autodesk GLC's key objectives for its North American Territory Sales. Working collaboratively with the executive staff and key internal stakeholders, you will drive policies and programs in line with the organization's strategic and operational priorities.

Responsbilities:

• Monitor the policies, practices and processes of GLC North America to determine efficiency and effectiveness. Recommend improvements and develops strategies to achieve and deliver improved results. Implement and follow standards as defined by Corporate and Division senior management; escalate exceptions or questionable practices to direct manager or senior management staff. This may include working with various data support teams, legal, PPL, and Corporate Compliance.
• Regularly interact with executives and/or major customers. Interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization.
• Manage and lead a team of top accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met. Responsible for the hiring, team effectiveness, culture, performance management and skill development of this team.
• Deliver timely and accurate forecasting of the business, within 2% variance, and pipeline management.
• Manage and develop resources (including consultants, vendors and remote workers, which may be in different time zones). This includes selection, mentoring/coaching, performance management and assessment, and rewards and recognition within own team.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of Autodesk, its licensing models, and industry best practices. Participate in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensure budgets and schedules meet corporate and divisional requirements.
• Lead or sponsor cross functional or intra-divisional projects for Global License Compliance North America, especially projects related to streamlining and/or improving processes and systems.
• Lead the way in working collaboratively with Territory sales teams on account planning activities to ensure the best customer experiences.
• Manage sales KPIs, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals, while ensuring that a balance of sales and enforcement activity is maintained.
• Strategically monitor and review long term goals of the program and ensure campaigns are executed within budget and that License Compliance revenue targets are met.
• May make presentations to existing and prospective customers about the benefits of Autodesk software and engage in final stage negotiation with C level customers and be a point of escalation.
• Manage both Direct and Indirect sales motions.
• Manage a complex volume business that may include highly technical lead sources; responsible for prioritizing various lead programs for the team to maximize effectiveness of the business.
• Collaborates on best practices and drives License Compliance strategies with other geographies and functional groups.

Minimum Qualifications

• 10+ years of relevant experience in technical software or SAAS/PAAS sales; 5+ sales leadership experience with track record of creating high-performing teams.
• Sales experience includes track record of success in difficult negotiations with C-level, handling accounts in the enterprise segment, and conflict resolution.
• Experience in effectively managing a complex, volume-based and digital business and comfortable interfacing with stakeholders at all seniority levels.
• Familiarity with technology, licensing models, and business trends in Autodesk target industries.

Preferred Qualifications:

• Experience or knowledge in Cyber security practices or License Compliance industry
• Experience selling in value-based models
• Ability to build relationships at multiple levels
• Self-motivated with the ability to adapt to changing priorities and business initiative

About Autodesk

Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Benefits

From health and financial benefits to time away and everyday wellness, we give Autodeskers the best, so they can do their best work. Learn more about our benefits in the U.S. by visiting https://benefits.autodesk.com/

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Equal Employment Opportunity

At Autodesk, we're building a diverse workplace and an inclusive culture to give more people the chance to imagine, design, and make a better world. Autodesk is proud to be an equal opportunity employer and considers all qualified applicants for employment without regard to race, color, religion, age, sex, sexual orientation, gender, gender identity, national origin, disability, veteran status or any other legally protected characteristic. We also consider for employment all qualified applicants regardless of criminal histories, consistent with applicable law.

Diversity & Belonging

We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

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Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

 We are looking for professionals to grow with us and we have an exciting opportunity in our Finance group.  The Director US Tax Compliance - in close alignment with the Regional Head of Tax Americas - will manage the tax compliance processes for Lonza US entities (timely preparation and filing of all federal, state and local tax returns,  management of direct and indirect tax audits, tax support to Lonza businesses) and will work in the specific tax projects (research, studies, analysis, preparation of memos and presentations etc.) assigned by the Regional Head of Tax Americas

In this role, the Director US Tax Compliance will work with the Lonza US tax team/staff, by managing and coordinating the necessary activities, and will be directly involved (“hands-on”) in the preparation/review/analysis needed to successfully execute the tax compliance processes and the projects assigned.   

Key responsibilities:

• Coordinate the timely preparation and review of all federal, state, local tax returns for Lonza US Group US (including the US tax compliance of the non-US legal entities owned via Lonza US group) to ensure timely filing and compliance with applicable laws and regulations.  Manage the process of the return preparation by Lonza US tax team/staff.  Collect, analyze, and format financial information, work with Lonza US finance and accounting departments to gather information needed to complete all required tax forms/reports.  Manage tax compliance team/staff to assist in the collection of data and ensure that the information is properly reviewed to minimize errors.  Set deadlines with tax compliance team/staff for the completion of projects so that sufficient time is available to review information in detail prior to filing with tax authorities.
• Maintain tax software to be used to prepare all federal and state tax returns for Lonza US entities. 
• Maintain a tax depreciation software database to be used in order to correctly calculate the Federal and State Depreciation adjustments. 
• Preparation and review of estimated tax payments calculations to minimize excess tax payments and liaising with Lonza US Treasury department to pre-inform on the payments amount expected and to be executed.
• Investigate and implement tax optimization opportunities, including income exclusions and tax credits, to be pre-discussed and aligned with the Regional Head of Tax Americas. Ensure that best practices are employed to efficiently gather, use, document, and maintain the related supporting documentation in line with the applicable law and regulations. 
• Maintain professional and technical knowledge by attending educational workshops or classes; reviewing professional publications; establishing personal networks, and participating in professional societies.
• Manage the various tax notices and exams in such a manner that the position is knowledgeable enough of the laws/requirements so that the position can answer IRS and or state authority’s questions and concerns.
• Assist in the effective and efficient tax transition and consolidation of newly acquired Lonza’s entities under the Lonza US tax umbrella.
• Perform tax analysis/researches and prepare memorandums and presentations in relation to specific tax projects assigned by the Regional Head of Tax Americas
• Manage, under the lead of (and in close alignment with) the Regional Head of Tax Americas, federal, state & local tax audits from various US jurisdictions, negotiate with tax authorities and defend the positions taken by Lonza by maintaining complete and accurate files.  Make sure that sufficient information is gathered and maintained during the tax returns process to support amounts that might be questioned in the future under audit.
• Responsible for FATCA Compliance and maintaining W-8BENE forms and W-9 forms for all units within and out of the US.
• In close alignment with the Regional Head of Tax Americas, manage tax compliance team/staff and recommend and encourage training seminars to help them improve their tax knowledge and develop their careers.  Provide feedback to staff on projects completed.
• Align with Regional Head of Tax to ensure that Lonza’s global and US tax strategies and optimization of Lonza’s tax position are implemented and correctly reflected in the US tax returns and provisions.
• Frequently liaise with Regional Head of Tax Americas to discuss Lonza’s US tax position in general, and with respect to specific items identified as (materially) influencing Lonza’s US tax position. Timely inform Regional Head of Tax Americas about tax audits announced, and keep Regional Head of Tax Americas informed about progress and status of tax audits, discussing general approach, what information will be provided, negotiation positions, and the response to proposed adjustments.

Key requirements:

• Bachelors’ degree required, Masters’ degree in Taxation/Accounting preferred
• Significant years of experience in US Corporate Tax Compliance and Tax Accounting
• Experience leading multiple complex initiatives simultaneously
• Flexibility and willingness to perform other tasks assigned
• Ability to gather and organize large amounts of highly technical and specialized information from numerous sources
• Significant work experience interfacing with Tax function colleagues in US and Globally
• Highly proficient with time and process management

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Job Description

General Summary:

The Quality Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the cell and gene therapy business unit.  The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance. 

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• Leads inspection and compliance programs both internally and externally.  Works cross-functionally across many different functional areas and programs. 
• Provide leadership, strategic thinking, and mentorship to staff, focusing on employee development and leadership skills
• Leads and manages complex projects/teams within corporate objectives and project timelines
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies
• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products

  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Solid quality culture knowledge and understanding of how to influence and improve overall compliance

  • Strong presentation skills and ability to influence others

  • Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Job Description

General/Position Summary

The Senior Director, Quality be responsible for the oversight of Product Quality/ External Manufacturing of Cell & Gene Programs.  The role will be responsible for supporting the commercial transition of the Cell & Gene quality  strategy to meet business, regulatory and operational requirements.

The is a critical role within Quality department responsible for managing CDMO partnerships to ensure that the company effectively and efficiently delivers medicines to patients. This role is also directly responsible for co-leading joint project teams with CDMO’s.

This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will partner closely with operational stakeholders to ensure seamless supply of all clinical and commercial products and to lead/support the development and execution of quality projects.   The senior director of quality will also participate in Cell & Genetic therapies projects and governance committees covering external manufacturing. 

**This is a hybrid role working 3 days on-site and up to two days remotely.**

Key Duties & Responsibilities

• Establishment of quality oversight for external CMO operations.
• Prioritize, develop and implement systems, processes and tools to ensure that the systems, processes and resourcing are optimal for transition from development through product life cycle and set up to scale efficiently and effectively.
• Ensure appropriate metrics and tracking are in place for operational monitoring and as early key indicators for operational issues.
• Represent Quality in Cell & Gene Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
• Support GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
• Provides quality leadership and partner with operational stakeholders to ensure efficient operations and mitigation of risks. Support/lead risk management activities, including identification of gaps, implementation of mitigation plans and associated execution.
• Provide significant CDMO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the CDMOs.  Adjudicate compliance discussions, and negotiate any required corrective actions.
• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities and talent building.

Required Education Level

• Bachelor’s and Master's degree in a Scientific/Technical/Business discipline.

Required Experience

• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Experienced in quality assurance operations role  for a allogeneic/autologous cell manufacturing process.
• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Current knowledge of industry trends and best practices in Cell/Gene therapies.
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinking and Problem Solving skills

Other Requirements
 

15% travel

Hybrid role in Boston, MA

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

DIRECTOR, CLINICAL QUALITY THERAPEUTIC AREA LEAD

Live

What you will do

Job Description

Let’s do this! Let’s change the world! In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ) and be responsible for a team of 5-10 colleagues. The Director, Clinical Quality Therapeutic Area Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program.

Director, Clinical Quality Therapeutic Area Lead will manage end to end Quality Oversight within one of three Therapeutic Areas (TAs): Oncology/Biosimilars, Immunology & Rare Diseases, and General Medicine. The TA Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will be a vital role who develops deep knowledge of the TA’s clinical trials and provides oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities

• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
• Provide oversight for the development and implementation of Quality Plans
• Establish Regional expertise to ensure quality and compliance to local regulations
• Support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
• Develop TA-specific Quality Assurance plans that are risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits)
• Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness activities, and Inspection Management, and Serious Breaches/ Privacy Issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:

Basic Qualifications:

Doctorate degree and 4 years of Quality Management, Quality Assurance, or other relevant experience

Or

Master’s degree and 8 years of Quality Management, Quality Assurance, or other relevant experience

Or

Bachelor’s degree and 10 years of Quality Management, Quality Assurance, or other relevant experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Qualifications:

• 5 years of managerial experience directly leading people in a multi-tiered organization and an ability to build a high performing team.
• 5 years or more experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
• Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise. (including oversight of CAPAs, deviations, etc.)
• Thorough understanding and deep knowledge of Clinical Development activities / Clinical Trials and Global Regulations.
• Knowledge of the Regulatory Submission and Inspection Management procedures.
• Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions.
• Excellent verbal and written communication skills, including strong business writing abilities and active listening.
• Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
• Strong analytical, critical-thinking, and decision-making abilities.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range