Associate Director, Quality Assurance (GMP Operations)

Role: Associate Director, Quality Assurance – GMP Operations at Gilead, overseeing quality leadership for manufacturing and QC at Foster City site during the startup and operation of a state-of-the-art biologics facility. Responsibilities: ensure GMP compliance across product lifecycle, oversee external QC labs, review investigations and deviations, apply risk management principles, support regulatory inspections, and drive continuous quality improvements; lead and develop QA team; collaborate cross-functionally with manufacturing, engineering, and supply chain. Requirements: 10+ years in GMP environment (biologics preferred), Bachelor's degree in science or related field, proven experience supporting GMP manufacturing and QC, leading investigations, and managing quality systems; strong understanding of cGMP, ICH guidelines, and risk management tools. Preferred: experience with Health Canada or FDA inspections. High-value specifics: biologics, GMP manufacturing, QC, inspections, risk management, digital manufacturing startup. Work setup: onsite Foster City, CA; no explicit travel stated.