Senior Manager, Quality Assurance (GMP Operations)
Gilead Sciences
August 20, 2026
On-site
San Francisco Bay Area
Operations
Sr Manager Quality Assurance – GMP Operations (Site-based, Foster City, CA)
Responsibilities
- Provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC).
- Ensure GMP compliance through design, startup, and operation of a new Single Use DS Biologics manufacturing facility and QC laboratory.
- Manage/prioritize/participate in batch record review and release; review manufacturing, environmental monitoring, and QC data; responsible for final product release.
- Provide QA oversight of external QC labs; ensure method lifecycle (qualification/verification/validation) complies with cGMP, ICH, and internal standards (review/approve protocols, reports, methods).
- Review/approve laboratory investigations (e.g., OOS/OOT/deviations) ensuring robust root cause analysis and CAPA; support aligned product quality/disposition decisions.
- Manage/review QC data for method establishment, qualification/validation, and transfer.
- Apply Quality Risk Management principles to oversee risk assessments with Manufacturing and QC.
- Author/review/approve changes to controlled documents (SOPs, specifications, forms) to ensure GMP/GLP compliance.
- Participate in planning/design of biologics facility and QC lab; support site inspection readiness and internal audits.
- Participate in continuous improvement and partner to resolve quality issues.
- Participate in review/approval of Deviations, CAPAs, and Change Management records.
Knowledge/Skills (required/preferred)
- In-depth GMP/GLP knowledge; QA principles and international quality systems regulations.
- Communication skills (verbal/written/interpersonal).
- Computer System Validation (CSV) and electronic records/signatures.
- Preferred: Six Sigma/DMAIC, quality statistical methods; Risk tools (HACCP/FMEA); ASQ certification.
Education/Experience
- 8+ years GMP-related experience with BS/BA OR 6+ years with MS OR 2+ years with PhD.
- Experience across Quality Assurance/Quality Systems; interacting with regulatory agencies.
- Knowledge of risk management tools (e.g., HACCP, FMEA).
Benefits/Compensation
- Salary range: $157,590.00–$203,940.00; may be eligible for discretionary bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).
Responsibilities
- Provide Quality leadership and direct quality oversight of Manufacturing and Quality Control (QC).
- Ensure GMP compliance through design, startup, and operation of a new Single Use DS Biologics manufacturing facility and QC laboratory.
- Manage/prioritize/participate in batch record review and release; review manufacturing, environmental monitoring, and QC data; responsible for final product release.
- Provide QA oversight of external QC labs; ensure method lifecycle (qualification/verification/validation) complies with cGMP, ICH, and internal standards (review/approve protocols, reports, methods).
- Review/approve laboratory investigations (e.g., OOS/OOT/deviations) ensuring robust root cause analysis and CAPA; support aligned product quality/disposition decisions.
- Manage/review QC data for method establishment, qualification/validation, and transfer.
- Apply Quality Risk Management principles to oversee risk assessments with Manufacturing and QC.
- Author/review/approve changes to controlled documents (SOPs, specifications, forms) to ensure GMP/GLP compliance.
- Participate in planning/design of biologics facility and QC lab; support site inspection readiness and internal audits.
- Participate in continuous improvement and partner to resolve quality issues.
- Participate in review/approval of Deviations, CAPAs, and Change Management records.
Knowledge/Skills (required/preferred)
- In-depth GMP/GLP knowledge; QA principles and international quality systems regulations.
- Communication skills (verbal/written/interpersonal).
- Computer System Validation (CSV) and electronic records/signatures.
- Preferred: Six Sigma/DMAIC, quality statistical methods; Risk tools (HACCP/FMEA); ASQ certification.
Education/Experience
- 8+ years GMP-related experience with BS/BA OR 6+ years with MS OR 2+ years with PhD.
- Experience across Quality Assurance/Quality Systems; interacting with regulatory agencies.
- Knowledge of risk management tools (e.g., HACCP, FMEA).
Benefits/Compensation
- Salary range: $157,590.00–$203,940.00; may be eligible for discretionary bonus, discretionary stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions
- Apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).