Senior Manager, Quality Assurance (GMP Operations)

Role: Senior Manager of Quality Assurance – GMP Operations at Gilead, overseeing Quality leadership for manufacturing and QC at Foster City site. Objectives: ensure GMP compliance during design, startup, and operation of a state-of-the-art biologics facility, supporting biologics development in viral and inflammatory disease areas, including hepatitis C and HIV. Responsibilities: manage batch record review and product release, oversee external QC labs, review investigations (OOS/OOT), approve validation and transfer data, apply risk management tools, and participate in site audits and continuous improvement. Qualifications: 8+ years in GMP/QC environments, with a BS/BA, MS, or PhD; extensive experience with quality systems, regulatory interactions, and risk management principles; knowledge of GMP/GLPs, CSV, and quality standards. Preferred: certifications from ASQ or similar, experience in biologics manufacturing, and familiarity with Six Sigma, FMEA, HACCP methodologies. High-value specifics: biologics (cell/gene therapy modalities), late-stage development, GMP compliance, and quality oversight of manufacturing and QC processes. Collaboration: partners with manufacturing, QC, and regulatory teams. Location: Foster City, CA, onsite; no travel specified.