Manager, Quality Assurance

Job description

The Manager, Quality Assurance is responsible for supporting and maintaining compliance with the Quality Management System (QMS) and applicable regulatory requirements. This role ensures that manufacturing, testing, and release activities for cell therapy products are conducted in accordance with cGMP standards and company procedures. The position provides day-to-day oversight of Quality Assurance activities, supports cross-functional teams, and contributes to risk assessment and continuous improvement initiatives. This role supports operations across the Santa Monica, CA and Tarzana, CA sites and reports to the Director of Quality Site Head. Key Responsibilities: Support management of the Quality Assurance team, including training, scheduling, and performance support of QA staff. Provide QA support to cross-functional groups including Manufacturing, Quality Control, Supply Chain, Process Development, and Regulatory Affairs. Ensure compliance with internal quality systems, regulatory requirements, and cGMP standards. Review batch records and associated documentation to support timely product disposition and release. Review and approve deviations, investigations, CAPAs, and change c...