Director, Quality Compliance

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Job description

Director, Quality Compliance
United States - New Jersey - Morris Plains

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:

Reporting to the Sr. Director, Site Quality Head, the Director, Quality Compliance leads the Quality Compliance function within the NJ Quality including the following programs: Deviations, CAPA, Risk Management, Computer System Quality, Equipment & Utilities Quality, Submission Data Verification, Self-Inspections, Internal Audit, and Inspection Readiness/Management. The Director, Quality Compliance plays a critical role in ensuring a continuous and sustainable state of GMP compliance.

Essential Duties and Job Functions:

• Lead the following Quality Compliance programs, ensuring compliance with Gilead Policies and Standards: Deviations, CAPA, Risk Management, Computer System Quality, Equipment & Utilities Quality, Submission Data Verification, Self-Inspections, Internal Audit, and Inspection Readiness/Management.
• Ensure compliance by sustaining a level of inspection readiness by maintaining and improving appropriate systems, processes, and procedures to meet regulatory requirements, guidelines and industry standards.
• Maintain and deploy Risk Management process for Gilead NJ.
• Own the Quality Investigations and CAPA Management processes, oversee root cause analysis and product impact investigations for major and critical deviations; ensure appropriate CAPAs implemented to mitigate risk.
• Lead the internal audit program to ensure stakeholder system compliance with existing policies and procedures.
• Facilitate and participate in Health Authority Inspections.
• Generate the annual internal audit schedule in conjunction with corporate audit function.
• Assist in determining appropriate CAPA plans to address identified deficiencies, prevent reoccurrences of similar events, or prevent occurrence of potential nonconformances identified during investigations.
• Assist the Data Integrity Governance Committee with DI Investigations.
• Ensure Data Integrity of data submitted to regulatory agencies in support of submissions.
• Oversees the IT Quality and Equipment Quality function.
• Make recommendations to management regarding results of internal and external audits.
• Provide QA advice to stakeholders (e.g. manufacturing, laboratories) based on analyses and interpretation of cGxP regulations.

Knowledge, Experience and Skills:

• 10+ years of relevant experience and a Bachelor's degree in science or related fields. OR 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Prior people management experience.
• Broad experience across QA, Validation, Drug development experience and understanding of Parenteral, Aseptic and API operations is beneficial.
• Biopharmaceutical experience preferred. Flexible, highly motivated, with strong organizational skills, and analytical problem solving, and conflict resolution skills.
• Training in investigations technique and root cause analysis tools (5 WHYs, Fishbone analysis, Is/Is-not, etc.) is preferred.
• Knowledge of relevant GMP regulations and guidance to include but not limited to 21 CFR, ICH, EU GDP/GMP, PIC/S.
• Must be proficient with all MS Office applications.
• Ability to work independently and to make decisions based on experience.
• Position is based in Morris Plains, NJ, with flexible working environment.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:
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