Senior Manager, Quality Assurance
Gilead SciencesUnited States - California - Foster City · full time · Senior
$157,590 – $203,940
Listed on Gilead Sciences’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
This role manages Gilead's global quality agreement program as a subject matter expert, handling template development, regulatory compliance, and stakeholder collaboration across manufacturing partnerships. It suits experienced quality professionals with strong regulatory knowledge who can lead complex cross-functional initiatives in a highly regulated pharmaceutical environment.
Our summary, not Gilead Sciences’s wording. The full posting is on their site.
Skills this role names
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What they ask for
Required
- 8+ years in GMP-related field with BS/BA, or 6+ years with MA/MS, or 2+ years with PhD/PharmD
- Expertise in quality agreement development, negotiation, lifecycle management, and governance in global GMP environment
- Strong knowledge of global regulatory requirements (FDA, EMA, ICH) applicable to quality agreements
- Advanced stakeholder management and negotiation skills across cross-functional teams
- Ability to manage complex, high-visibility programs with multiple concurrent deliverables
- Strong technical writing skills for drafting and standardizing quality agreement templates
- Fast learner who operates effectively in highly regulated environments
Nice to have
- Experience working with Contract Manufacturing Organizations (CMOs) and external partners
- Experience interacting with regulatory authorities and supporting quality agreement inspections
- Experience managing global programs or serving as a Global Process Owner (GPO)
- Familiarity with digital document management or contract lifecycle management tools
- Working knowledge of digital Quality Management Systems and Veeva Vault