Total 16 Director/C-Level Quality Assurance / Control job vacancies in NT - Regional and Remote - Alice Springs

EL1 Assistant Director, Audit and Assurance
About the Role:
Our Federal Government client is seeking a dynamic individual for the position of Assistant Director, Audit and Assurance. This role is integral to supporting Australia's clean energy transition and involves leading internal audit, fraud and corruption control, and general assurance activities. The successful candidate will work closely with various business areas and stakeholders to ensure effective achievement of organizational goals.
Key Responsibilities:

Internal Audit: Collaborate with the internal audit service provider to support the internal audit program. This includes developing audit scopes, planning audit activities, and managing Management Initiated Reviews.
Fraud and Corruption Control: Conduct regular fraud and corruption risk assessments, improve control plans, and engage with external stakeholders in the fraud and corruption control space.
Cross-Team Support: Provide support to the Risk and Audit Committee, monitor audit reports, and update management on relevant findings
... Click here to view more detail / apply for EL1 Assistant Director, Audit and Assurance

The Opportunity:  
We have an exciting opportunity at Newcastle Anglican for our new Director Risk & Compliance. This vacancy has an essential role in developing the strategic response to risk, ensuring effective insurance and establishing a critical incident response framework.
This role is perfect for an experienced Risk & Compliance leader who enjoys owning a process and making an impactful change to the organisation. This includes raising the risk management profile and maturity across the organisation and ensuring its readiness for critical events.
This is a Permanent Full Time vacancy.
Why Work for us?  
Newcastle Anglican places people at the centre of our work. As a part of working for a faith-based organisation, you will have access to the following great benefits: 

Work for a purpose-driven organisation where you can access opportunities for growth and advancement across all of our

... Click here to view more detail / apply for Director Risk and Compliance

Clough has an exciting opportunity for a highly experienced Chief Instrumentation and Control Engineer to join our in-house Engineering Team in our Perth office! In this role, you will effectively provide overall leadership, technical authority, coordination and development of the process and process safety discipline, working closely with engineering managers (corporate and project) to ensure timely, cost effective and fit for purpose engineering and design output.
Who we are
We are a pioneering project delivery company. We harness innovative engineering and construction solutions to improve peoples? lives today and tomorrow.
We deliver high performing assets for the energy, resources and infrastructure industries, underpinned by a dedication to innovation, sustainability and getting the job done safely and efficiently. Together with our parent company, Webuild, we are delivering some of Australia?s largest projects.
Who you are
Courageous. Innovative. Passionate. Creative. These are just a few words that ... Click here to view more detail / apply for Chief Instrumentation & Control Engineer

EL1 Assistant Director, Audit and Assurance
About the Role:
Our Federal Government client is seeking a dynamic individual for the position of Assistant Director, Audit and Assurance. This role is integral to supporting Australia's clean energy transition and involves leading internal audit, fraud and corruption control, and general assurance activities. The successful candidate will work closely with various business areas and stakeholders to ensure effective achievement of organizational goals.
Key Responsibilities:

Internal Audit: Collaborate with the internal audit service provider to support the internal audit program. This includes developing audit scopes, planning audit activities, and managing Management Initiated Reviews.
Fraud and Corruption Control: Conduct regular fraud and corruption risk assessments, improve control plans, and engage with external stakeholders in the fraud and corruption control space.
Cross-Team Support: Provide support to the Risk and Audit Committee, monitor audit reports, and update management on relevant findings
... Click here to view more detail / apply for EL1 Assistant Director, Audit and Assurance

Clough has an exciting opportunity for a highly experienced Chief Instrumentation and Control Engineer to join our in-house Engineering Team in our Perth office! In this role, you will effectively provide overall leadership, technical authority, coordination and development of the process and process safety discipline, working closely with engineering managers (corporate and project) to ensure timely, cost effective and fit for purpose engineering and design output.
Who we are
We are a pioneering project delivery company. We harness innovative engineering and construction solutions to improve peoples? lives today and tomorrow.
We deliver high performing assets for the energy, resources and infrastructure industries, underpinned by a dedication to innovation, sustainability and getting the job done safely and efficiently. Together with our parent company, Webuild, we are delivering some of Australia?s largest projects.
Who you are
Courageous. Innovative. Passionate. Creative. These are just a few words that ... Click here to view more detail / apply for Chief Instrumentation & Control Engineer

EL1 Assistant Director, Audit and Assurance
About the Role:
Our Federal Government client is seeking a dynamic individual for the position of Assistant Director, Audit and Assurance. This role is integral to supporting Australia's clean energy transition and involves leading internal audit, fraud and corruption control, and general assurance activities. The successful candidate will work closely with various business areas and stakeholders to ensure effective achievement of organizational goals.
Key Responsibilities:

Internal Audit: Collaborate with the internal audit service provider to support the internal audit program. This includes developing audit scopes, planning audit activities, and managing Management Initiated Reviews.
Fraud and Corruption Control: Conduct regular fraud and corruption risk assessments, improve control plans, and engage with external stakeholders in the fraud and corruption control space.
Cross-Team Support: Provide support to the Risk and Audit Committee, monitor audit reports, and update management on relevant findings
... Click here to view more detail / apply for EL1 Assistant Director, Audit and Assurance

EL1 Assistant Director, Audit and Assurance
About the Role:
Our Federal Government client is seeking a dynamic individual for the position of Assistant Director, Audit and Assurance. This role is integral to supporting Australia's clean energy transition and involves leading internal audit, fraud and corruption control, and general assurance activities. The successful candidate will work closely with various business areas and stakeholders to ensure effective achievement of organizational goals.
Key Responsibilities:

Internal Audit: Collaborate with the internal audit service provider to support the internal audit program. This includes developing audit scopes, planning audit activities, and managing Management Initiated Reviews.
Fraud and Corruption Control: Conduct regular fraud and corruption risk assessments, improve control plans, and engage with external stakeholders in the fraud and corruption control space.
Cross-Team Support: Provide support to the Risk and Audit Committee, monitor audit reports, and update management on relevant findings
... Click here to view more detail / apply for EL1 Assistant Director, Audit and Assurance

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

Director Asset Strategy, Programs & Compliance
Apply now Job no: 536118 Work type: Ongoing full-time Location: All of NSW, Armidale, Coffs Harbour, Newcastle, Orange, Parramatta, Wagga Wagga Categories: Director, Senior Executive, Environmental Science, Project Management, Property and Asset Management, Legislation, Strategy, Senior Executive


Unique opportunity to utilise your strategic asset management skills in a dynamic role
Permanent full-time role available with a flexible/hybrid working model
Location negotiable across NSW with main offices in Parramatta, Newcastle, Coffs Harbour, Orange, Armidale and Wagga Wagga
TRP from $225k to $249k including superannuation, commensurate with experience

Are you a dynamic leader with a passion for strategic asset management and compliance? Do you thrive in environments where your expertise can drive impactful change for communities? If so, we have a rewarding opportunity for you!


... Click here to view more detail / apply for Director Asset Strategy, Programs & Compliance

Executive Director - Quality and Patient Safety (528713) Department of Health Hospitals & Primary Care - Hospitals Nth Hospitals & Primary Care - Hospitals Nth Applications must be submitted by Sunday 28 April, 2024 11:55 PM Position details Applications close: Sunday 28 April, 2024 11:55 PM AEST Award/Classification: Health and Human Services (Tasmanian State Service) Award, General Stream, Band 9 Salary: $165,446 to $182,913 per annum Employment type: Full Time Region: North Location: LGH Charles Street, Launceston Job description: The Executive Director of Quality and Patient Safety (EDQPS) is responsible for the effective leadership and management of the Hospital’s North Safety, Quality, Risk and Service Program and for providing leadership and direction in the ongoing strategic development and evaluation of quality and patient safety systems and processes within a clinical governance framework. Provide effective and inclusive implementation of the National Safety & Quality Health Service (NSQHS) Standards accreditation scheme, the National Aged Care Quality Standards,…

Click here to view more detail / apply for Executive Director - Quality and Patient Safety (528713)

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

ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future.

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:

$92,986.00 - $158,076.00

Nationwide Remote Office (US99)

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

Our search for better is changing the lives of our customers. It’s changing the careers of our people too –creating new challenges and opportunities all the time. We’re a business that never stands still. Join us on our journey to #ForeverCaring as a Senior Director, Quality (Complaint Handling and Post Market Surveillance), and you won’t either.

 

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!

Located just outside the Universal Orlando™ theme parks, our Lakewood Regional Support Facility serves as the central operation for all our on-site hotels. Lakewood provides resources to the hotels for various departments, including Human Resources, Purchasing, Accounting, Security, Group Reservations, Telecommunications, Technology and Laundry.

Purpose:

The Director of Compensation & Compliance has direct oversight of Loews Hotels Universal Orlando compensation and compliance programs to include related workflow and system integration. The role is responsible for ensuring HR processes adhere to Loews Hotels & Co standards and comply with applicable Federal, State and Local laws.

Essential Functions and Responsibilities:

• Plans, directs, supervises, and coordinates work activities of team relating to the HR compensation and compliance function.
• Manages compensation programs for Loews Hotels Universal Orlando to include job offers, wage increases, and other compensation related changes.
• Proactively monitors internal and external factors that may influence wage practices and presents recommendations at quarterly Regional Compensation Committee meetings.
• Ensures practices are compliant with company’s exempt salary structure and guidelines.
• Responsible for developing and managing non-exempt compensation guidelines.
• Oversees messaging to team members to promote clarity and reinforce the value of compensation programs.
• Prepares and presents annual wage budget proposals.
• Administers the company’s short term incentives program for Orlando properties.
• Analyzes and modifies HR processes, workflows, and practices to establish conformity with Loews Hotels & Co standards and ensure compliance with legal requirements.
• Stays abreast of regulatory, market, relevant case-law decisions, and HR industry trends to help formulate changes to operating standards.
• Advise managers on organizational policy matters such as: EEO, affirmative action, FCRA, FLSA, joint-employment, NLRA, FMLA, and all other pertinent laws related to the HR function. Department may be responsible for auditing and executing regulatory compliance programs.
• Responsible for HR Compliance function's daily activities including record keeping, auditing, data integrity and work process flow compliance.
• Plans and conducts HR audits throughout the year to adhere compliance with applicable standards.
• Oversees compliance of the I-9 program to include work authorization tracking.
• Performs other related duties as assigned.

Required Qualifications:

• Strong acumen related to Human Resource laws, regulations, and best practices.
• Proficient in MS Office. 
• Working knowledge of HRIS systems, experience with Workday preferred.
• Excellent written and verbal communication skills.
• Excellent organizational and time management skills.
• Attention to detail and accuracy.
• Strong analytical and problem-solving skills.
• Able to work independently and as part of a team.

Education and Experience:

• 5 years of progressive Human Resources experience.  Experience should include responsibilities for ensuring operational practices were compliant with employment regulations.
• At least 2 years of experience leading and directing a team.
• Experience in auditing and/or project management strongly preferred.

Career Category

Operations

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

187,972.00 USD - 214,012.00 USD

A Vacancy at Birmingham and Solihull Mental Health NHS Foundation Trust.


This is an amazing leadership role in one of the most innovative mental health trusts in the country, at a pivotal time when the opportunities to make a real difference for the future have never been greater. As Executive Director of Quality and Safety (Chief Nurse) you will provide strong clinical leadership, enhance relationships with our partners to progress joint working, and uphold our values of being Compassionate, Committed, and Inclusive.

As with other health and care organisations, we are delivering services under significant financial and operational pressures. However, we see many examples of progress and positive developments as well as recognising the areas that we still need to improve upon.

This is an amazing leadership role in one of the most innovative mental health trusts in the country, at a pivotal time when the opportunities to make a real difference for the future have never been greater. As Executive Director of Quality and Safety (Chief Nurse) you will provide strong clinical leadership, enhance relationships with our partners to progress joint working, and uphold our values of being Compassionate, Committed, and Inclusive.

If you are looking for a role which presents an exciting leadership challenge, both within our Trust and as part of the wider health and care system, then we welcome your interest and application.

As a voting member of the Trust Board the post holder will contribute to the full range of corporate decision making, strategy and policy development. They will attend and participate in Board and Committee meetings, making a full contribution to Board business and the Trust’s agenda.
Working closely with other executive colleagues, the post holder will be responsible to the Chief Executive and Trust Board for service user and patient healthcare outcomes, safety and experience. The post holder will be the professional lead for the majority of clinical professions (with the exception of the Medical and Psychological therapies professions), including nursing, Allied Health Professionals and social work. The post holder will be the Board lead for quality governance, quality improvements and assurance alongside the Executive Medical Director, and will fulfill the functions of the Board-level Nurse for the Trust.
Following the Trust becoming the Lead Provider for the Birmingham and Solihull Mental Health Provider Collaborative in April of this year, the post holder, alongside executive colleagues, will have a key role in delivery of the collaborative’s objectives, ensuring our commissioning arm is
operating appropriately and the development of a needs assessment-based strategy.

Welcome to Birmingham and Solihull Mental Health NHS Foundation Trust. Our 4000 clinical and support staff help us to improve mental health wellbeing and meet the needs of the 70,000 people we serve each year. We provide a range of mental healthcare services across Birmingham and Solihull, as well as specialised services nationally. We also offer medical, nursing and psychology training and are proud of our international reputation for both research and innovation.

Our population is culturally diverse, characterised in places by high levels of deprivation which create an increasing demand for our services and a necessity for us to make sure everyone can access the help they need. We are a team of compassionate, inclusive and committed people working together to provide excellent care to support our community. If you are looking for a place to belong, where you can make a real difference to people's lives, join our team where our warm welcome is waiting for you.

For further information about the main responsibilities please view the attached job description and person specification.

This role gives the opportunity for hybrid working and you will typically be asked to work in a hybrid way, working from your home and also from Trust HQ The Uffculme Centre, or any other agreed site.


This advert closes on Sunday 14 Jan 2024