Associate Director, Quality Assurance (GMP Operations)

Responsibilities

• Provide senior Quality leadership and direct oversight of GMP Manufacturing and Quality Control (QC) operations at the Foster City site.
• Ensure GMP compliance through the design, startup, and operation of a new biologics manufacturing facility and QC laboratory.
• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to support timely product disposition.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
• Provide Quality Assurance strategy and oversight of external QC laboratories, including the review of protocols, reports, and methods.
• Lead, develop, and mentor Quality personnel, fostering an inclusive and empowering team environment.
• Serve as a key Quality contact during regulatory inspections and internal audits.

Requirements

• 10+ years of relevant GMP experience with a Bachelor's degree in science or a related field; OR 8+ years with an MS; OR 5+ years with a PharmD/PhD.
• Extensive hands-on experience supporting biologics, GMP Manufacturing, and QC operations.
• Proven experience leading investigations, CAPA, and change management in a GMP operational environment.
• Previous experience in people management within a Quality function.
• Strong understanding of materials management, manufacturing, and analytical testing systems.

Preferred Qualifications

• Experience supporting Health Canada, FDA, or other global regulatory inspections.
• Certification by ASQ (e.g., CQA, CQE, or CQM) or other industry-recognized professional organizations.
• Knowledge of Six Sigma, DMAIC methodology, and Risk Management tools such as HACCP or FMEA.

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.