Total 7 Director/C-Level Quality Assurance / Control job vacancies in AMER - United States - California - Offsite/Home

As Director of the Acquisitions Division the incumbent will be responsible for providing the day-to-day management, planning, leadership and oversight of a full range of acquisitions and contract administration activities.The incumbent will provide managerial leadership, technical direction and oversight for OIG Acquisitions Division as follows:

• Directs all contracting and procurement activities;
• Provides advise and technical information;
• Advises, guides and collaborates with OIG senior-level management officials to develop and formulate acquisition plans and policies;
• Directs the planning and execution of pre-award and post-award contracting functions;
• Directs the procurement of equipment, supplies and services and the award, administration and close-out of contracts;
• Develops and administers the small and disadvantaged business program;
• Serves as a technical expert and senior Contracting Officer for OIG with unlimited signatory authority;
• Represents the Agency in non-litigation dealings with GSA, GAO, OMB, Congress and other organizations with oversight authority for OIG; and
• Assumes the full range of supervisory responsibilities for staff members directed by this position.

• 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

Job Description:

Baptist Health is looking for a Regional Director, Compliance and Privacy - East to join our team. This is a remote position that requires residency in KY, IN, or IL

Directs and monitors physician practice-related compliance activities on a daily basis which may include more than 50 physical locations and/or more than 200 physicians and non-physician practitioners as well as their support staff, including practice acquisitions in the assigned region.  Contributes to the fulfillment of the mission and vision by planning, designing, implementing and maintaining professional practice programs, policies and procedures.  Assists in the implementation of system-wide and professional practice policies and procedures, develops and conducts educational programs and administers reviews related to the Baptist Health HIPAA Privacy Program.  Oversees all ongoing regional activities related to the development, implementation, maintenance of and adherence to the Baptist Health policies and procedures covering the privacy of, and access to Protected Health Information (PHI) in compliance with federal and state laws and BHS policies and procedures.

Responsible for the due diligence on compliance-related issues and determines the appropriate corrective action, to include the identification of operational gaps, process improvement needs, identification of educational opportunities and coordinating resolution.  Communicates findings and recommendations to the BHMG regional leadership team and facilitates effective resolutions in a timely manner.

This position requires frequent travel within assigned region (up to 60%).  Travel expenses may be reimbursable according to the Baptist Health Travel policy. 

Minimum Requirements

• A bachelor’s degree with a minimum of five years of experience in physician practice operations, compliance, medical billing, or related area is required. 

• Minimum of three years of management experience in physician practice operations, compliance, or other related area is required.  (A minimum of five years' work experience which demonstrates strong leadership may be considered in lieu of management experience.)

• Demonstrated leadership skills with strong commitment to assume responsibility and effectively collaborate across all levels of an organization.

• Physician Coding Certification (by AHIMA and/or AAPC) and/or Certification in Compliance (HCCA or AAPC) and experience in physician procedural and diagnosis coding, third party payer reimbursement, and CMS requirements specific to Medicare Part B preferred.

• Exceptional organizational and time management skills and the ability to maintain strict confidentiality at all times is required.

If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now!

Baptist Health is an Equal Employment Opportunity employer.

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

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

Your opportunity

IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.

You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators. 

As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.

Your key responsibilities will include:

Strategic Leadership:

• Oversee IQVIA’s Code of Conduct and ethics and compliance policies.

• Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.

• Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.

• Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.

• Conduct sensitive investigations as needed.

Collaboration and Stakeholder Management:

• Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.

• Build collaborative relationships with external parties such as auditors, law firms, and regulators.

People Leadership:

• Manage at least one employee.

• Report directly to the Chief Compliance Officer.

• Drive a culture of ethics and integrity throughout the organization.

To be successful on this role, you will have qualifications such as:

• Subject Matter Expertise:

  • Stay informed about global laws, regulations, and codes of ethics.

  • Provide guidance to leadership, management, and employees.

  • JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.

  • Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.

• Ethics Line Management:

  • Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.

  • Ensure compliance with EU whistleblower laws and other relevant regulations.

• Risk Assessment:

  • Utilize deep subject matter knowledge to assess risks across various areas.

  • Experience managing Codes of Conduct and corporate policies.

  • Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.

  • Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.

  • Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.

You will differentiate yourself if you have:

• Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).

• Life sciences outsourcing experience (e.g., CRO).

Location

• IQVIA currently offers remote work arrangements.

• The incumbent must be based anywhere on the East Coast of the United States.

How to Apply

If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.

We look forward to welcoming a dedicated leader to our team! 🌟

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

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

JOB DESCRIPTION:

WORKING AT ABBOTT:

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

THE OPPORTUNITY:

The Director of Technical Quality Support is responsible for directing a team of quality engineers focused on validation and design control of products and processes, including software and technical quality assurance personnel. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight for FDA communications regarding compliance issues. Provide strategic consulting for the division by interfacing directly with the divisions on policy development and deployment. Develop and assess key metrics. Provide senior management with impact of regulatory changes.

This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements.

Work effectively with multiple different divisions and medical device technologies.

Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.

Responsible for:

Quality assurance activities for software and firmware development for health care products, including both medical and non-medical applications

Quality assurance activities for hardware development for health care products.

Creating and maintaining an efficient, highly motivated, quality engineering organization.

WHAT YOU’LL WORK ON:

• Provide overall direction and leadership for validation, design and qualification to assure product quality for application software, embedded firmware and hardware products for medical monitoring systems.
• Develop, implement and improve quality policies, processes and procedures, automated systems and reporting systems.
• Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department.
• The incumbent must understand the details of the areas involved. Possess strong leadership skills, an overall knowledge of healthcare industry regulations, ability to effectively negotiate and strong communication skills.
• Provide strategic consulting for programs being developed or implemented.
• Facilitate policy development and deployment throughout the corporation.
• Work to achieve program standardization between businesses.
• Develop and assess metrics for each center.
• Lead and facilitate implementation of new regulations.
• Train our various businesses on new requirements for compliance.
• Standardize approach to implementation of new regulations.
• Provide oversight of quality and compliance goals.
• Interface directly with the divisions on policy development and deployment
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
• Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process, including on-market risk evaluation and assessments. Making decisions on whether or not to take action on market to remedy non-conforming product on-market.
• Utilizes practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) experience with Agile/Lean software development lifecycle process
• Complies with worldwide regulations, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Assure line of communication with DVP QA and Senior Leaders on critical quality issues that may result in potential business interruption.
• Assure business continuity in leadership positions and critical roles through talent management planning and development.

QUALIFICATIONS:

• Bachelor's Degree in Engineering, Computer Science or technical discipline or equivalent experience in software field.
• Master’s degree in a technical discipline ideal.
• Minimum 10 years in Progressive work experience in software related medical device or high technology industries. Minimum 10 years prior management experience.
• Requires technical background and direct experience of product development activities for software and/or hardware for leading edge medical devices.
• Demonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the products.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to travel, including internationally >50% of time.

APPLY NOW:

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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