OOS & Expanded Access Program Manager

Kite Pharma, Inc.; El Segundo (CA); On-site; USD 133,000 - 172,000; Full time

Job summary

Kite Pharma is seeking a Manager, OOS & Expanded Access Program to lead end-to-end OOS and EAP work for our cell therapy portfolio in the United States. This role requires cross-functional leadership, regulatory awareness, and a strong operations mindset to ensure compliant, timely management of OOS events and expanded access for new launches.

Responsibilities include designing SOPs, developing a sIND portal, coordinating with Regulatory, Quality, Clinical Operations, and Field Medical, and

Qualifications

• MA/MS with 4+ years relevant clinical or life sciences experience OR BA/BS/RN with 6+ years relevant clinical or life sciences experience.
• Experience in cell therapy manufacturing/supply chain, apheresis, lot release, and chain-of-identity/chain-of-custody processes.
• Familiarity with FDA/EMA guidelines, ICH guidelines, GCP and Medical Affairs compliance frameworks.

Responsibilities

• Lead the end-to-end OOS program for Kite’s cell therapy products, including single patient INDs and Expanded Access Program integration.
• Develop and maintain SOPs, work instructions, and ensure regulatory and safety compliance.
• Design, implement, and manage the sIND portal and coordinate with regulatory, quality, and clinical operations teams.
• Coordinate OOS risk assessments and medical affairs implications.
• Oversee EAP delivery for new cell therapy launches, ensuring regulatory and safety compliance across processes.
• Cross-functional collaboration with QA, regulatory, safety, supply chain, and medical affairs.

Skills

Cross-functional leadership

Analytical thinking

Regulatory awareness

Communication

Education

MA/MS in life sciences

BA/BS/RN with 6+ years experience

Tools

Veeva Vault

MedComms

Quality

TrackWise

Salesforce/CRM

Power BI

Tableau

Job description

Kite Pharma is seeking a Manager, OOS & Expanded Access Program to lead end-to-end OOS and EAP work for our cell therapy portfolio in the United States. This role requires cross-functional leadership, regulatory awareness, and a strong operations mindset to ensure compliant, timely management of OOS events and expanded access for new launches.

Responsibilities include designing SOPs, developing a sIND portal, coordinating with Regulatory, Quality, Clinical Operations, and Field Medical, and