Director, Quality Assurance Operations

Role: Director of Quality Assurance Operations overseeing cGMP compliance for clinical-stage gamma delta T cell therapies, supporting manufacturing, quality systems, and regulatory submissions. Responsibilities: build and lead QA operations, ensure cGMP adherence during phase I-III clinical manufacturing, manage lot disposition, review validation and development activities, lead investigations, oversee raw material QA, and represent QA during audits. Collaborate cross-functionally with Manufacturing, Facilities, QC, Supply Chain, Regulatory, and others; champion risk management and continuous improvement initiatives. Requirements: Bachelor's in life sciences; 10+ years in regulated biotech/pharma, with 6+ years in QA roles, plus 5+ years of management experience; mastery of cGMP, FDA CFR, EMA, ICH regulations; experience with health authority inspections and electronic quality management systems. Preferred: prior cell therapy experience. HighValue: cell therapy, clinical development, cGxP, regulatory compliance, validation, and audits. WorkSetup: onsite at Redwood City, CA, with travel as needed.