Gilead Sciences
Associate Director, GVP Audits
Join Gilead Sciences where we are creating a healthier world for all people. The Associate Director, GVP Audits will lead internal and external pharmacovigilance (GVP) audit activities across the organization.
Job Description Responsible for executing internal GVP audits, supporting digital audits, and leading complex audits across R&D, vendor, and pharmacovigilance workstreams. Collaborates with cross‑functional stakeholders, shapes the R&D Quality Annual Audit Program, and supports regulatory inspections and risk readiness.
Primary Responsibilities
Accountable for oversight and completion of broad GVP audit activities across affiliates, partners and vendors.
Lead internal R&D quality audits for assigned groups or locations.
Provide subject matter expertise and support to project teams.
Drive continuous improvements in R&D quality processes, systems and standards.
Plan, schedule, and conduct GVP audits in accordance with the audit plan.
Prepare and deliver high‑quality audit reports and track CAPA effectiveness.
Collaborate with R&D Quality Business Partners and stakeholder SMEs.
Support inspection readiness and preparation for external reviews.
Oversee contractor auditors and ensure timely completion of deliverables.
Qualifications
PharmD, PhD, or advanced degree in Life Sciences with at least 2–10 years of quality compliance experience.
Extensive experience leading GVP audits in the biopharma industry.
Proficiency in GVP regulatory requirements (FDA, EMA, ICH).
Strong understanding of GxP auditing and CAPA processes.
Excellent communication, problem‑solving, and stakeholder‑management skills.
Preferred Qualifications
Experience with E‑System/Digital audits and cross‑functional project teams.
Lean Six Sigma or similar continuous improvement methodology.
Certification as a Quality Auditor.
Benefits Competitive base salary ($182,070–$235,620), discretionary bonus, long‑term equity, comprehensive medical, dental, vision, and life insurance, paid time off and a culture of inclusion and diversity.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, gender identity and expression, veteran status, or other protected characteristics. For more information about equal employment opportunity protections, please view the “Know Your Rights” poster.
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Job Description Responsible for executing internal GVP audits, supporting digital audits, and leading complex audits across R&D, vendor, and pharmacovigilance workstreams. Collaborates with cross‑functional stakeholders, shapes the R&D Quality Annual Audit Program, and supports regulatory inspections and risk readiness.
Primary Responsibilities
Accountable for oversight and completion of broad GVP audit activities across affiliates, partners and vendors.
Lead internal R&D quality audits for assigned groups or locations.
Provide subject matter expertise and support to project teams.
Drive continuous improvements in R&D quality processes, systems and standards.
Plan, schedule, and conduct GVP audits in accordance with the audit plan.
Prepare and deliver high‑quality audit reports and track CAPA effectiveness.
Collaborate with R&D Quality Business Partners and stakeholder SMEs.
Support inspection readiness and preparation for external reviews.
Oversee contractor auditors and ensure timely completion of deliverables.
Qualifications
PharmD, PhD, or advanced degree in Life Sciences with at least 2–10 years of quality compliance experience.
Extensive experience leading GVP audits in the biopharma industry.
Proficiency in GVP regulatory requirements (FDA, EMA, ICH).
Strong understanding of GxP auditing and CAPA processes.
Excellent communication, problem‑solving, and stakeholder‑management skills.
Preferred Qualifications
Experience with E‑System/Digital audits and cross‑functional project teams.
Lean Six Sigma or similar continuous improvement methodology.
Certification as a Quality Auditor.
Benefits Competitive base salary ($182,070–$235,620), discretionary bonus, long‑term equity, comprehensive medical, dental, vision, and life insurance, paid time off and a culture of inclusion and diversity.
Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, gender identity and expression, veteran status, or other protected characteristics. For more information about equal employment opportunity protections, please view the “Know Your Rights” poster.
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