Associate Director, Quality Assurance (GMP Operations)
Gilead Sciences
August 20, 2026
On-site
San Francisco Bay Area
Operations
Site-based role (Foster City, CA)
Knowledge
- In-depth knowledge of GMPs and/or GLPs; QA principles, concepts, industry practices, and standards.
- Understanding of Computer Systems Validation and ICH Guidelines.
- Excellent verbal, written, and interpersonal communication skills.
- Knowledge of Six Sigma, DMAIC, performance measures, and quality improvement statistics.
- Working knowledge of Risk Management tools (e.g., HACCP and/or FMEA).
- ASQ certification (Certified Quality Auditor/Engineer/Manager) or other industry-recognized professional organization.
Key Responsibilities
- Provide Quality Assurance oversight of GMP manufacturing and QC testing from master cell bank to drug product.
- Define and oversee external QC laboratories; ensure qualification/verification/validation comply with cGMP, ICH, and internal standards (review/approve protocols, reports, and methods).
- Review/approve laboratory investigations (e.g., OOS/OOT/deviations); ensure root cause analysis, robust CAPA, and decisions aligned to product quality/disposition.
- Apply Quality Risk Management to oversee risk assessments with Manufacturing and QC.
- Partner to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Justify/document quality risk decisions per internal procedures and regulatory expectations.
- Resolve quality issues across manufacturing, laboratory activities, and material receipt/shipping; oversee digital manufacturing workflow implementation.
- Review/approve manufacturing and test records, deviations, investigations, change controls, and CAPA for timely product disposition.
- Evaluate operational and quality risks for new product introductions.
Compliance, Audits & Inspections
- Participate in internal GMP audits and walkthroughs (Manufacturing, QC, Warehouse).
- Key Quality contact for regulatory inspections/internal audits; prepare and respond to findings.
- Monitor regulatory requirements and assess compliance risks.
Quality Systems & Documentation
- Approve GMP documentation (risk assessments, procedures, master batch records, specifications, analytical methods); drive continuous improvement.
Leadership & Collaboration
- Lead, develop, and mentor Quality personnel supporting GMP operations.
- Partner cross-functionally (Manufacturing, QC, Process Development, Engineering, Supply Chain, Quality management).
- Lead/support quality-related operational projects; provide on-call QA support as needed.
- Use risk-based decision making; maintain knowledge of Health Canada, FDA, and global GMP expectations.
Education & Experience (Requirements)
- 10+ years relevant GMP-environment experience with a Bachelor’s in science/related field OR 8+ years with an MS OR 5+ years with a PharmD/PhD.
- Extensive hands-on biologics GMP manufacturing and QC operations experience.
- Proven experience leading investigations, CAPA, and change management in GMP environment.
- Strong materials management, manufacturing/analytical methods, and GMP testing systems experience.
- Previous people management experience in Quality.
- Strong cross-functional collaboration and communication.
Preferred
- Experience supporting Health Canada, FDA, or other regulatory inspections.
Benefits (as stated)
- Salary range: $182,070.00 - $235,620.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.
Knowledge
- In-depth knowledge of GMPs and/or GLPs; QA principles, concepts, industry practices, and standards.
- Understanding of Computer Systems Validation and ICH Guidelines.
- Excellent verbal, written, and interpersonal communication skills.
- Knowledge of Six Sigma, DMAIC, performance measures, and quality improvement statistics.
- Working knowledge of Risk Management tools (e.g., HACCP and/or FMEA).
- ASQ certification (Certified Quality Auditor/Engineer/Manager) or other industry-recognized professional organization.
Key Responsibilities
- Provide Quality Assurance oversight of GMP manufacturing and QC testing from master cell bank to drug product.
- Define and oversee external QC laboratories; ensure qualification/verification/validation comply with cGMP, ICH, and internal standards (review/approve protocols, reports, and methods).
- Review/approve laboratory investigations (e.g., OOS/OOT/deviations); ensure root cause analysis, robust CAPA, and decisions aligned to product quality/disposition.
- Apply Quality Risk Management to oversee risk assessments with Manufacturing and QC.
- Partner to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Justify/document quality risk decisions per internal procedures and regulatory expectations.
- Resolve quality issues across manufacturing, laboratory activities, and material receipt/shipping; oversee digital manufacturing workflow implementation.
- Review/approve manufacturing and test records, deviations, investigations, change controls, and CAPA for timely product disposition.
- Evaluate operational and quality risks for new product introductions.
Compliance, Audits & Inspections
- Participate in internal GMP audits and walkthroughs (Manufacturing, QC, Warehouse).
- Key Quality contact for regulatory inspections/internal audits; prepare and respond to findings.
- Monitor regulatory requirements and assess compliance risks.
Quality Systems & Documentation
- Approve GMP documentation (risk assessments, procedures, master batch records, specifications, analytical methods); drive continuous improvement.
Leadership & Collaboration
- Lead, develop, and mentor Quality personnel supporting GMP operations.
- Partner cross-functionally (Manufacturing, QC, Process Development, Engineering, Supply Chain, Quality management).
- Lead/support quality-related operational projects; provide on-call QA support as needed.
- Use risk-based decision making; maintain knowledge of Health Canada, FDA, and global GMP expectations.
Education & Experience (Requirements)
- 10+ years relevant GMP-environment experience with a Bachelor’s in science/related field OR 8+ years with an MS OR 5+ years with a PharmD/PhD.
- Extensive hands-on biologics GMP manufacturing and QC operations experience.
- Proven experience leading investigations, CAPA, and change management in GMP environment.
- Strong materials management, manufacturing/analytical methods, and GMP testing systems experience.
- Previous people management experience in Quality.
- Strong cross-functional collaboration and communication.
Preferred
- Experience supporting Health Canada, FDA, or other regulatory inspections.
Benefits (as stated)
- Salary range: $182,070.00 - $235,620.00; may be eligible for discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits including company-sponsored medical, dental, vision, and life insurance.
Application Instructions
- Apply via the Internal Career Opportunities portal in Workday.