Senior Manager, QC Technical Operations
Core
Lead Quality Control site startup and operational oversight for clinical and commercial manufacturing of advanced therapies in a GMP facility.
Role type
Senior Manager, QC Technical Operations
Builds
New QC facility capabilities for US and EU markets, microbiology function, and quality systems.
Domain
Biotechnology / Advanced Therapies (Cell & Gene Therapy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, clean room qualification (ISO 14644), compendial safety testing, rapid methodologies (BacT), gene and cell therapy testing (qPCR/ddPCR, Flow Cytometry, ELISA, cell-based assays), LIMS/CMMS/QMS/ERP systems, team supervision, laboratory investigations.
Preferred skills
Cell and gene therapy manufacturing environment experience.
Responsibilities
Own QC procedure revisions, support tech transfer and program onboarding, develop and maintain laboratory systems, plan and implement site training and EM/aseptic programs, review and trend data for management, oversee laboratory excursions (deviations, OOS, OOT), participate in regulatory inspections, hire, train, and mentor staff.
Seniority
Senior, hands-on IC with management responsibilities