Senior Manager, Quality Assurance

Role: Senior Manager, Quality Assurance at Gilead, serving as the Global Process Owner for the Global Quality Agreement Program. Objectives include establishing and maintaining compliant, effective quality agreements globally, supporting continuous improvement, and ensuring regulatory adherence. Responsibilities encompass developing standard templates and guidance, managing lifecycle and negotiations of Quality Agreements, collaborating with Legal and external partners, monitoring regulatory trends, and supporting inspections. Qualifications: 8+ years in a GMP environment, with a BS/BA; or 6+ years with an MA/MS; or 2+ years with a PhD/PharmD. Skills include expertise in Quality Agreements, global regulatory requirements (FDA, EMA, ICH), strong technical writing, stakeholder management, and negotiation. Preferred experience with CMOs, regulatory interactions, digital quality systems (e.g., Veeva Vault), and global program management. The role involves high engagement with internal stakeholders and external partners, supporting a broad scope of GMP activities related to external quality oversight. Location: role details do not specify, but imply a global/regional scope with potential for remote or hybrid work. The position offers a competitive salary range ($157,590–$203,940) with bonuses, stock incentives, and comprehensive benefits.