Director, Quality Compliance and Audits
Gilead Sciences
August 14, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Director, Quality Compliance and Audits (QCA)
Responsibilities
- Provide strategic leadership and governance for the global GMP/GDP audit program.
- Lead and develop an auditing team; manage work planning, prioritization, performance monitoring, coaching, feedback, and reviews.
- Establish and execute a risk-based annual audit plan.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit coverage.
- Conduct/support GMP/GDP audits across internal sites and external partners (contract manufacturers, labs, suppliers, distributors, other third parties) across small molecules, biologics, and medical devices/combination products.
- Ensure consistent audit execution (observation writing, finding classification, risk assessment, documentation).
- Identify, assess, and escalate compliance risks/systemic issues; ensure documentation, trending, escalation, and resolution.
- Guide use of AI-enabled tools/digital solutions to improve audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation/application of regulatory requirements.
- Support development/implementation of audit processes, tools, templates, and systems; oversee audit-program systems/data integrity.
Supervisory
- Supervise direct reports and contingent workforce/consultants; develop talent via mentoring.
Qualifications / Skills
- Required: biotech/pharma industry experience; proven GMP/GDP auditor with experience leading/managing/developing auditors.
- Desirable: experience with Health Authorities; prior regulatory authority experience.
- Expert knowledge of GMP/GDP regulations, regulatory expectations, inspection practices.
- Strong communication across technical/operational/executive audiences; analytical judgment; independent decision-making; issue escalation and results orientation.
Education/Experience
- BS/BA (12+ years) or MS/MA (10+ years) in Biology/Sciences/related field, or equivalent.
Travel
- 30% travel required.
Benefits / Compensation (as stated)
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities
- Provide strategic leadership and governance for the global GMP/GDP audit program.
- Lead and develop an auditing team; manage work planning, prioritization, performance monitoring, coaching, feedback, and reviews.
- Establish and execute a risk-based annual audit plan.
- Monitor regulatory requirements, enforcement trends, and inspection intelligence; incorporate insights into audit coverage.
- Conduct/support GMP/GDP audits across internal sites and external partners (contract manufacturers, labs, suppliers, distributors, other third parties) across small molecules, biologics, and medical devices/combination products.
- Ensure consistent audit execution (observation writing, finding classification, risk assessment, documentation).
- Identify, assess, and escalate compliance risks/systemic issues; ensure documentation, trending, escalation, and resolution.
- Guide use of AI-enabled tools/digital solutions to improve audit effectiveness, consistency, and efficiency.
- Provide expert guidance on interpretation/application of regulatory requirements.
- Support development/implementation of audit processes, tools, templates, and systems; oversee audit-program systems/data integrity.
Supervisory
- Supervise direct reports and contingent workforce/consultants; develop talent via mentoring.
Qualifications / Skills
- Required: biotech/pharma industry experience; proven GMP/GDP auditor with experience leading/managing/developing auditors.
- Desirable: experience with Health Authorities; prior regulatory authority experience.
- Expert knowledge of GMP/GDP regulations, regulatory expectations, inspection practices.
- Strong communication across technical/operational/executive audiences; analytical judgment; independent decision-making; issue escalation and results orientation.
Education/Experience
- BS/BA (12+ years) or MS/MA (10+ years) in Biology/Sciences/related field, or equivalent.
Travel
- 30% travel required.
Benefits / Compensation (as stated)
- May be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.