Senior Director, Quality Systems and Compliance

Role: Senior Director of Quality Systems and Compliance responsible for shaping and executing global quality and compliance strategies to support clinical and commercial readiness of Allogene's allogeneic CAR T cell products. Responsibilities: lead the Quality Management System, ensure compliance with cGMP and international standards (FDA, EMA, ICH, ISO), oversee inspection readiness, manage supplier quality, and drive continuous improvement initiatives; foster a culture of quality across functions including Manufacturing, Regulatory, and Clinical Quality Assurance; develop quality metrics and KPIs; build and develop a high-performing team. Qualifications: B.S. in Biological Sciences, Chemistry, Engineering; 10-12+ years in pharma/biotech with 5-6+ years managing quality systems, including experience with regulatory inspections and global compliance; strong knowledge of quality requirements for biotech manufacturing; excellent communication and risk management skills; adaptable to fast-paced environments. HighValue: focus on GxP compliance, inspection readiness, supplier quality, and digital quality initiatives in a cell therapy context; experience with pre-approval and inspection management. WorkSetup: based in South San Francisco, hybrid (up to 2 days remote).