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

Role: Manage the Out-of-Specification (OOS) and Expanded Access Program (EAP) for Kite's cell therapy portfolio, ensuring compliant, efficient handling of OOS events and EAP delivery for new therapies. Responsibilities: establish and oversee the enterprise OOS framework, develop SOPs, lead risk assessments, and serve as the primary Medical Affairs liaison for EAP operations, including developing a streamlined sIND portal and coordinating across functions like Regulatory, Quality, Clinical Operations, and Safety. Qualifications: MA/MS with 4+ years or BA/BS/RN with 6+ years relevant clinical or life sciences experience; strong clinical operations expertise. Preferred: experience in cell therapy manufacturing, supply chain, regulatory submissions (IND/sIND), deviations, CAPA, and familiarity with systems such as Veeva Vault, TrackWise, Salesforce, and data visualization tools. High-Value: cell therapy (CAR T), EAP delivery, sIND portal development, compliance with FDA/EMA regulations, cross-functional leadership, and risk management. WorkSetup: Not specified; likely office-based with collaboration across global teams.