Senior Manager, Quality Assurance
Gilead Sciences · Foster City, CA
QualityFull-time$158k–$204kCompany career page
The apply link worked recently (not employer-confirmed).
What they're looking for
- 8+ years GMP environment experience with bachelor's degree, or 6+ years with master's degree, or 2+ years with PhD/PharmD
- Expertise in quality agreement development, negotiation, lifecycle management, and governance
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH) applicable to quality agreements
- Advanced technical writing skills for drafting and standardizing quality agreement templates
- Cross-functional stakeholder management, influencing, and negotiation capabilities
- Experience managing complex, high-visibility programs with multiple concurrent deliverables
- Preferred experience with contract manufacturing organizations and regulatory authority interactions
What you'll be doing
- Serve as global process owner for quality agreement program, ensuring compliance and consistent implementation
- Develop and maintain standardized quality agreement templates, guidance documents, and training materials
- Provide subject matter expertise on quality agreement content, interpretation, and applicability to internal and external stakeholders
- Drive alignment and resolution of complex quality agreement terms across legal, sourcing, and quality teams
- Establish governance processes, metrics, and reporting to ensure program transparency and effectiveness
Privacy & handoff
This role links to Gilead Sciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.