Senior Manager, Quality Assurance (GMP Operations)

Responsibilities

• Provide Quality leadership and direct oversight of Manufacturing and Quality Control (QC) at the Foster City site.
• Ensure GMP compliance through the design, startup, and operation of a new biologics manufacturing facility and QC laboratory.
• Manage and prioritize batch record reviews and release activities for in-process and finished products.
• Provide QA oversight of external QC laboratories, including the review of method lifecycle activities and protocols.
• Review and approve laboratory investigations (OOS/OOT/deviations) and ensure robust CAPA implementation.
• Apply Quality Risk Management principles to oversee risk assessments in collaboration with Manufacturing and QC teams.
• Author, review, and approve standard operating procedures, specifications, and other controlled documents.
• Participate in site inspection readiness, internal audits, and continuous improvement initiatives.

Requirements

• 8+ years of GMP experience with a BS/BA, 6+ years with an MS, or 2+ years with a PhD.
• In-depth knowledge of GMP and GLP standards.
• Experience interacting with regulatory agencies.
• Experience across broad areas of Quality Assurance and/or Quality Systems.
• Knowledge of Risk Management tools such as HACCP and FMEA.
• Excellent interpersonal, verbal, and written communication skills.

Preferred Qualifications

• Knowledge of Six Sigma and DMAIC methodology.
• Experience with Computer System Validation (CSV) and electronic record requirements.
• Professional certification from ASQ (CQA, CQE, or CQM).

About the Company

Gilead Sciences 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 are dedicated to developing therapies that improve lives and ensuring access to these treatments across the globe.