Director, Analytical Quality Assurance

Key Responsibilities
- Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations, ensuring scientific soundness, risk-based quality decisions, and regulatory compliance.
- Provide quality governance for contract partners and testing laboratories; partner cross-functionally with Manufacturing and external partners to support product lifecycle and regulatory priorities.
- Lead the Analytical Quality Assurance team and foster a strong quality culture.

Job Responsibilities
- Provide quality oversight for contract QC testing laboratory activities, stability programs, analytical method validation, and transfers.
- Review/approve analytical quality documents (SOPs, specifications, methods, change controls, protocols, reports, investigations, deviations, CAPAs, quality assessments).
- Ensure analytical testing complies with cGMP, GLP, ICH, and applicable regulatory requirements (e.g., FDA/EMA).
- Oversee investigations for OOS/OOT/atypical results, deviations, and lab incidents; ensure timely resolution and appropriate CAPA recommendations.
- Oversee contract partners/labs (qualification, performance monitoring, audits, quality agreements, resolution of compliance/documentation issues).
- Maintain/improve systems for CAPA, change control, risk management, compliance, and analytical quality operations.
- Manage audits/inspections for analytical labs and testing activities (regulatory, customer, internal, cGMP compliance).
- Review/audit analytical data and CMC sections of NDA/global regulatory filings (as applicable).
- Manage direct reports in Analytical Quality Assurance.

Knowledge/Experience/Skills
- Evaluate analytical data, investigations, trends, and product quality risks for risk-based decisions.
- Oversee contract testing labs/external partners (performance monitoring, issue resolution, quality governance).
- Strong communication, collaboration, organization, influencing, critical thinking, problem-solving, and independent decision-making.
- Lead/coach teams; build accountability, quality, and continuous improvement.

Qualifications
- Pharmaceutical quality/analytical sciences/Quality Control/Quality Assurance or related GMP-regulated environment with progressive leadership.
- Preferred: BS/BA (12+ years), MS (10+ years), or PhD (8+ years) in chemistry, microbiology, or related.

Benefits (if eligible)
- Company-sponsored medical, dental, vision, and life insurance; paid time off.

Application Instructions
- Apply via the Internal Career Opportunities portal in Workday (for current Gilead employees/contractors).