Manager, Quality Assurance – Western U.S. (West of the Mississippi) & Florida
Core
Manage qualification, monitoring, and compliance for apheresis collection and treatment centers supporting Kite's CAR-T cell therapy products.
Role type
Manager, Quality Operations
Builds
Validated state of courier tracking, order intake, and processing systems; compliant ATC networks.
Domain
Biopharmaceuticals / Cell Therapy / Quality Assurance
Required skills
GMP, FACT/AABB standards, audit management, CAPA, change control, risk-based qualification, regulatory agency interaction, supply chain management, MS Office proficiency
Preferred skills
Biological sciences background, apheresis/transplant/infusion center experience, deviation management, external supplier management, clinical research experience, ASQ Certified Quality Auditor
Technologies
GVault, Kite Konnect, MS Word, Excel, PowerPoint
Responsibilities
Assess and approve changes to order processing systems; manage ATC qualification and disqualification; perform audits and monitor compliance; maintain monitoring schedules and ATC lists; resolve ATC and courier issues; support inspection readiness plans; travel up to 40%.
Seniority
Manager, hands-on IC