Associate Director, Quality Assurance Compliance
Gilead Sciences
August 22, 2026
Remote friendly (San Francisco Bay Area)
United States
Operations
Associate Director, Quality Assurance Compliance
Responsibilities:
- Manage logistics for regulatory inspections at GSI Foster City (notification, IST, prep/inspection rooms, post-inspection activities and documentation).
- Build inspection readiness tools/templates/training; maintain inspection readiness resources (MSTeams/SharePoint) and evidence binders/storyboards.
- Coordinate inspections with cross-functional teams; manage inspection systems and inspection-related training.
- Oversee regulatory inspection procedures/documentation (e.g., Regulatory Inspection Policy, Site Master File, Opening Presentation); lead PAI readiness (mock inspections, global best-practice sharing).
- Design and implement inspection strategies/plans across manufacturing sites; standardize inspection procedures.
- Ensure regulatory compliance (FDA/EMA/others); assess CAPA in response to findings and provide management visibility; act as liaison for authority inquiries.
- Lead/support continuous improvement using quality data.
- Leverage digital/data/AI for inspection readiness and risk identification (GxP-compliant, governed/validated where required).
Requirements:
- BS/BA in Biology/Sciences + 10+ years; OR MS/MA + 8+ years; OR PhD + 5+ years.
- Biotech/pharmaceutical inspection experience.
- Manage Health Authorities during inspection (investigator experience preferred) and manage business partners.
- Knowledge of global/domestic regulations (e.g., 21 CFR parts; EudraLex Vol 4; EU GDP/GMP; QMSR/ISO13485; ICH/ISO/USP/EP).
- Detailed manufacturing/testing knowledge (APIs and multiple modalities/processes incl. aseptic, packaging, warehousing/distribution).
- Strong computer skills (Word/Excel/PowerPoint/MSTeams/Veeva Vault) and working knowledge of AI/analytics; ability to translate insights into inspection-ready narratives.
People leader accountabilities: create inclusion, develop talent, empower teams.
Salary range: Bay Area $182,070–$235,620; Other US $165,495–$214,170. Benefits include company-sponsored medical/dental/vision/life and may include bonus/stock/paid time off.
Application: Apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Manage logistics for regulatory inspections at GSI Foster City (notification, IST, prep/inspection rooms, post-inspection activities and documentation).
- Build inspection readiness tools/templates/training; maintain inspection readiness resources (MSTeams/SharePoint) and evidence binders/storyboards.
- Coordinate inspections with cross-functional teams; manage inspection systems and inspection-related training.
- Oversee regulatory inspection procedures/documentation (e.g., Regulatory Inspection Policy, Site Master File, Opening Presentation); lead PAI readiness (mock inspections, global best-practice sharing).
- Design and implement inspection strategies/plans across manufacturing sites; standardize inspection procedures.
- Ensure regulatory compliance (FDA/EMA/others); assess CAPA in response to findings and provide management visibility; act as liaison for authority inquiries.
- Lead/support continuous improvement using quality data.
- Leverage digital/data/AI for inspection readiness and risk identification (GxP-compliant, governed/validated where required).
Requirements:
- BS/BA in Biology/Sciences + 10+ years; OR MS/MA + 8+ years; OR PhD + 5+ years.
- Biotech/pharmaceutical inspection experience.
- Manage Health Authorities during inspection (investigator experience preferred) and manage business partners.
- Knowledge of global/domestic regulations (e.g., 21 CFR parts; EudraLex Vol 4; EU GDP/GMP; QMSR/ISO13485; ICH/ISO/USP/EP).
- Detailed manufacturing/testing knowledge (APIs and multiple modalities/processes incl. aseptic, packaging, warehousing/distribution).
- Strong computer skills (Word/Excel/PowerPoint/MSTeams/Veeva Vault) and working knowledge of AI/analytics; ability to translate insights into inspection-ready narratives.
People leader accountabilities: create inclusion, develop talent, empower teams.
Salary range: Bay Area $182,070–$235,620; Other US $165,495–$214,170. Benefits include company-sponsored medical/dental/vision/life and may include bonus/stock/paid time off.
Application: Apply via the Internal Career Opportunities portal in Workday.