QA Cryo Lead
Core
Lead Quality Assurance for CAR-T cell therapy cryopreservation operations, ensuring compliance and operational continuity in the EMEA region.
Role type
Senior IC Quality Assurance Lead (Cell & Gene Therapy)
Builds
CAR-T cell therapy products via cryopreservation center
Domain
Healthcare / Biopharmaceuticals / Cell & Gene Therapy
Required skills
GxP compliance, CAPA management, team leadership, batch release coordination, deviation management, change control, audit readiness, regulatory requirement implementation, lean improvement, Quality Agreements, Site Master Files
Preferred skills
Cell and gene therapy experience, supervisory experience, Tissues and Cells Directive knowledge, SAP/COMET/eLIMS experience, AI concepts and frameworks
Technologies
SAP, COMET, eLIMS, MES, Opstrakker
Responsibilities
Lead end-to-end QA oversight of nonconformance and CAPA management; coordinate key GxP processes including batch release and change control; lead and coach a team of QA Associates; serve as primary point of contact for QA Cryo; maintain audit and inspection readiness; drive implementation of new regulatory requirements; identify and implement improvement opportunities.
Seniority
Senior, hands-on IC with leadership responsibilities