Senior Manager, Quality Assurance
$157.59k - $203.94kGilead
Gilead Sciences seeks a Senior Manager of Quality Assurance for its Foster City manufacturing facility. This site-based role drives quality strategy and oversight across GMP operations, regulatory compliance, and product release, supporting facility startup and steady-state production of life-saving therapies.
Responsibilities
- Oversee GMP compliance, quality objectives, and regulatory requirements across manufacturing and QC testing operations
- Review and approve laboratory investigations, deviations, and CAPA recommendations from contract partners and internal teams
- Manage quality assurance personnel, organize workflow, conduct training, and perform performance reviews
- Approve GMP documentation including procedures, batch records, specifications, and analytical methods
- Lead internal audits, participate in regulatory inspections, and monitor compliance risks
Requirements
- In-depth knowledge of current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Deep expertise in quality assurance principles and regulatory requirements (FDA, Health Canada, ICH standards)
- Experience managing quality assurance personnel and leading cross-functional teams
- Demonstrated ability to conduct investigations, root cause analysis, and corrective/preventive action (CAPA) programs
- Strong knowledge of pharmaceutical product lifecycle from manufacturing through release
- Experience with quality risk management and statistical process control in manufacturing environments
Vacancy posted 1 day ago
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