QA Cryo Supervisor CAR-T
Core
Leads a team of QA Associates Cryo to ensure sustainable EMEA CAR-T Quality Assurance operations at the Beerse Cryopreservation Center.
Role type
Senior IC Quality Assurance Supervisor (Cell & Gene Therapy)
Builds
CAR-T cell therapy products via cryopreservation center operations
Domain
Biopharmaceuticals / Cell & Gene Therapy / Cryopreservation
Required skills
GxP compliance, batch record review, deviation handling, change controls, audit support, team leadership, stakeholder partnership, GMP/GDP knowledge
Preferred skills
Cell and gene therapy experience, supervisory experience, Tissues and Cells Directive knowledge, MES/Opstrakker experience, SAP/COMET/eLIMS familiarity
Technologies
MES, Opstrakker, SAP, COMET, eLIMS, Microsoft Office
Responsibilities
Lead and coach QA Associates Cryo team, perform day-to-day QA activities including batch release, partner with QA Manager on operational plans, serve as primary point of contact for daily operations, support GxP processes and audits, identify improvement opportunities, align objectives across Quality functions
Seniority
Senior, hands-on IC with team leadership