Technical Quality Control Senior Manager - Casgevy
Core
Lead QC operations for a gene-edited hemoglobinopathy cell therapy product, managing external CDMOs and QC labs to ensure GMP compliance and streamline commercial release.
Role type
Senior Manager, Technical Quality Control (Cell & Gene Therapy) (via careerplan.io/jobs/REQ-30275-technical-quality-control-senior-manager-casgevy-at-vrtx)
Builds
Commercial release of biologics and cell therapy products
Domain
Biopharmaceuticals / Cell and Gene Therapy
Required skills
GMP compliance, OOS/OOT investigations, reference standards management, stability studies, LIMS, raw materials testing, contract lab management, regulatory agency inspection experience, analytical method troubleshooting
Preferred skills
None stated
Technologies
LIMS
Responsibilities
Manage QC operations for gene-edited cell therapy products; oversee release and stability testing at external CDMOs; manage commercial reference standards and assay controls; lead OOS/OOT investigations and deviations; author and approve SOPs, COAs, and reports; ensure external lab records adhere to cGMP/GDP.
Seniority
Senior, hands-on IC
