This role is responsible for managing all regulatory inspection logistics, documentation, and readiness activities at the Foster City site and globally
Job Summary
This role is responsible for managing all regulatory inspection logistics, documentation, and readiness activities at the Foster City site and globally.
The position requires deep expertise in FDA and EMA regulations, including 21 CFR Parts 4, 11, and 211, to ensure strict compliance with quality standards.
Gilead offers a competitive salary range of $182,070.00 to $235,620.00 for Bay Area locations along with comprehensive benefits and discretionary bonuses.
Matching Summary
This role is responsible for managing all regulatory inspection logistics, documentation, and readiness activities at the Foster City site and globally.
Salary
Base: $182,070.00 - $235,620.00 (Bay Area); Base: $165,495.00 - $214,170.00 (Other US Locations); Bonus/Equity: Discretionary annual bonus and stock-based incentives; Benefits: Medical, dental, vision, life insurance
Skills & Requirements
Must-have
10+ years biotech or pharma experience
FDA and EMA regulatory knowledge
Inspection readiness and logistics management
21 CFR Parts 4, 11, 211 compliance
Mock inspection coordination
Nice-to-have
Previous Health Authority investigator experience
AI and machine learning in quality systems
Global inspection best practices collaboration
Strong matrix organization communication skills
Key Requirements
BS/BA degree with 10+ years experience OR MS/MA with 8+ years OR PhD with 5+ years
Experience managing Health Authorities during inspections
Knowledge of global GMP/GDP guidance and ICH standards