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

Role: Manager, Out-of-Specification (OOS) & Expanded Access Program at Kite, leading clinical operations of regulatory-compliant OOS event management and expanded access initiatives for cell therapy products. Responsibilities: establish and oversee enterprise OOS frameworks, develop SOPs, coordinate with cross-functional teams (Medical Affairs, Regulatory, Clinical Operations, Safety, Tech Ops), manage the delivery and compliance of EAPs, develop a sIND portal, and facilitate vendor relationships. Lead risk assessments, ensure regulatory adherence, and implement continuous improvement through analytics. Requirements: MA/MS with 4+ years or BA/BS/RN with 6+ years in clinical or life sciences; experience in cell therapy manufacturing/supply chain, familiarity with FDA/EMA regulations, EAP delivery, and regulatory submissions (IND/sIND). Skills: operational excellence, risk management, cross-functional leadership, compliance, analytical thinking, and clinical acumen. Preferred: experience with deviations, CAPA, data systems (Veeva, TrackWise, Salesforce, Power BI), and out-of-specification processes. High-Value: cell therapy, EAP, IND/sIND, regulated environment, cross-functional collaboration, GxP compliance, clinical operations, and vendor management. Location: not specified, likely hybrid or remote.