Manager, Out-of-Specification (OOS) & Expanded Access Program – Medical Affairs (Cell Therapy)

Role: Lead the end-to-end management of Out-of-Specification (OOS) events and Expanded Access Program (EAP) operations for Kite’s cell therapy portfolio, ensuring regulatory compliance, clinical integrity, and operational excellence. Responsibilities: establish and oversee OOS event management frameworks, develop SOPs, serve as the primary liaison for EAP activities, and lead sIND portal development. Collaborate cross-functionally with Medical Affairs, Regulatory, Quality, Clinical Operations, Manufacturing, and external vendors. Ensure compliance with FDA/EMA regulations, ICH guidelines, and GxP standards; support audits and inspections; develop training programs; and implement continuous process improvements. Requirements: MA/MS with 4+ years or BA/BS/RN with 6+ years relevant clinical or life sciences experience; strong clinical operations knowledge; familiarity with cell therapy manufacturing, regulatory submissions (sIND), and compliance frameworks. Preferred: experience in cell therapy supply chain, deviations and CAPA management, data systems (Veeva Vault, Power BI, TrackWise), and out-of-specification processes. HighValue: focus on cell therapy (CAR T), regulatory compliance, EAP delivery, portal development, and cross-functional leadership within a regulated biopharma environment. WorkSetup: not specified; likely hybrid or onsite based on role scope.