Manager, Quality - QC Analytical

Job description

How You’ll Make an Impact: The Quality Control Manager in San Clemente, CA oversees all QC laboratory operations and testing activities. This role supervises QC staff, ensures compliant and efficient lab execution, maintains cGMP compliance and data integrity, and provides technical leadership while keeping the laboratory inspection-ready and supporting project teams as needed. What You’ll Do: General laboratory Management - Oversees and assigns raw material, in-process, finished product, and stability testing across multiple pharmaceutical products to ensure timely batch release and stability commitments - Manages cGMP stability programs for clinical and commercial products and performs trend analysis to identify risks or emerging issues - Oversees the internal reference standard qualification, lifecycle management, and documentation program - Oversees method validations, verifications, transfers, and feasibility studies to support product development and commercialization - Oversees audit trail review process and 21 CFR Part 11 compliance - Evaluates internal versus external testing strategies and recommends improvements to optimize efficiency, cost, and compliance - Recommends l...