Quality Assurance Manager in San Carlos, California

Quality Assurance Manager (Contractor)

Supports the GMP QA team by providing quality oversight of GMP manufacturing activities at external vendors and managing internal/external GxP documentation. Reports to Director of GMP Quality.

Key responsibilities include QA oversight of QC activities (method validation, specifications, stability), management of deviations, OOX investigations, CAPAs, change controls, shelf-life extensions, and related documentation. Collaborates with PDM/CMC, Supply Chain, Analytical Development, and other teams to support GMP operations.

Provides quality SME support for Quality Systems including deviations, CAPA, and change control processes. Ensures GMP compliance for method validation, release testing, specifications, and stability studies for drug substances and products.

Reviews and approves CMO documents (e.g., batch records, specifications, labels) and ensures proper product disposition based on review of test data and executed records.

Requires a Bachelor's degree in a scientific/technical field and at least 5 years of GMP Quality experience in pharma, preferably in late-stage development and validation. Strong knowledge of global regulatory requirements and small molecule development is essential.

Preferred skills include strong problem-solving, teamwork, multitasking, and proficiency in Microsoft Office and related systems.