Associate Director, Quality Assurance Compliance
Gilead Sciences
August 22, 2026
Remote friendly (United States)
United States
Operations
Site-based in Foster City (on-site Tue/Wed/Thu); non-local may be remote.
Responsibilities:
- Manage logistics for regulatory inspections at GSI Foster City: notification, Inspection Support Team (IST), prep/inspection rooms, post-inspection activities.
- Build inspection readiness tools/templates/training; maintain inspection documentation retention/tracking.
- Coordinate post-inspection follow-up: upload to GVault, assess observations, maintain evidence binders/storyboards, inspection readiness coordination.
- Manage inspection systems (e.g., MS Teams, SharePoint, Zoom) and cross-functional inspection logistics.
- Own regulatory inspection procedures/documentation (e.g., Regulatory Inspection Policy, Site Master File) and lead PAI readiness (mock inspections, drills, global best-practice sharing).
- Design inspection strategies/inspection plans across manufacturing sites; establish standardized procedures; oversee advanced inspection technologies.
- Ensure regulatory compliance (FDA/EMA/others); assess and track CAPAs from inspection findings; liaison for GSI FC regulatory inquiries.
- Lead/support quality improvement; use digital/data/AI tools for inspection readiness and risk identification.
- May support audit programs (internal, site, affiliate, 3PL); travel up to ~50%.
Requirements:
- BS/BA (10+ yrs) OR MS/MA (8+ yrs) OR PhD (5+ yrs) in Biology/Sciences or related.
Skills/Knowledge (preferred/required):
- Biotech/pharma industry experience; experience managing Health Authorities; investigator experience preferred.
- Practical knowledge of global/domestic regulations (e.g., 21 CFR Parts 4, 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Vol 4; EU GDP; ISO/QMS; Health Canada GMP/GDP; ICH/ISO/USP/EP).
- Deep knowledge of API/drug product/biologics/asceptic fill/packaging/warehousing & distribution; audit/risk-based principles.
- Strong systems skills (Word/Excel/PowerPoint, MS Teams, Veeva Vault); working knowledge of AI/analytics and AI governance in GxP.
- Ability to translate complex data into inspection-ready narratives; strong leadership/communication in matrix environments.
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Benefits/Compensation:
- Salary range: Bay Area $182,070–$235,620; other US $165,495–$214,170. Potential annual bonus/long-term incentives; paid time off; benefits (medical/dental/vision/life).
Application:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Manage logistics for regulatory inspections at GSI Foster City: notification, Inspection Support Team (IST), prep/inspection rooms, post-inspection activities.
- Build inspection readiness tools/templates/training; maintain inspection documentation retention/tracking.
- Coordinate post-inspection follow-up: upload to GVault, assess observations, maintain evidence binders/storyboards, inspection readiness coordination.
- Manage inspection systems (e.g., MS Teams, SharePoint, Zoom) and cross-functional inspection logistics.
- Own regulatory inspection procedures/documentation (e.g., Regulatory Inspection Policy, Site Master File) and lead PAI readiness (mock inspections, drills, global best-practice sharing).
- Design inspection strategies/inspection plans across manufacturing sites; establish standardized procedures; oversee advanced inspection technologies.
- Ensure regulatory compliance (FDA/EMA/others); assess and track CAPAs from inspection findings; liaison for GSI FC regulatory inquiries.
- Lead/support quality improvement; use digital/data/AI tools for inspection readiness and risk identification.
- May support audit programs (internal, site, affiliate, 3PL); travel up to ~50%.
Requirements:
- BS/BA (10+ yrs) OR MS/MA (8+ yrs) OR PhD (5+ yrs) in Biology/Sciences or related.
Skills/Knowledge (preferred/required):
- Biotech/pharma industry experience; experience managing Health Authorities; investigator experience preferred.
- Practical knowledge of global/domestic regulations (e.g., 21 CFR Parts 4, 11, 203, 205, 210, 211, 600, 610, 820; EudraLex Vol 4; EU GDP; ISO/QMS; Health Canada GMP/GDP; ICH/ISO/USP/EP).
- Deep knowledge of API/drug product/biologics/asceptic fill/packaging/warehousing & distribution; audit/risk-based principles.
- Strong systems skills (Word/Excel/PowerPoint, MS Teams, Veeva Vault); working knowledge of AI/analytics and AI governance in GxP.
- Ability to translate complex data into inspection-ready narratives; strong leadership/communication in matrix environments.
People Leader Accountabilities:
- Create Inclusion; Develop Talent; Empower Teams.
Benefits/Compensation:
- Salary range: Bay Area $182,070–$235,620; other US $165,495–$214,170. Potential annual bonus/long-term incentives; paid time off; benefits (medical/dental/vision/life).
Application:
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.