Senior Specialist, Cell Therapy Vein-to-Vein Process Excellence & Quality Operations
Core
Implement, standardize, and continuously improve end-to-end Vein-to-Vein processes for complex, personalized cell therapies, ensuring patient and product traceability and inspection readiness.
Role type
Senior Specialist, Process Excellence & Quality Operations
Builds
Scalable Vein-to-Vein operational workflows, controlled documentation, and quality controls for patient and product journeys.
Domain
Biopharma / Cell Therapy / Regulated Supply Chain
Required skills
Process mapping, Root-cause analysis, Risk assessment, GxP/GDP compliance, Deviation/CAPA management, Change control, Stakeholder management, Data analysis, SOP development, Continuous improvement
Preferred skills
Cell therapy/autologous supply chain experience, Cold-chain logistics, Lean/Six Sigma, FMEA, Digital capability deployment, Process governance
Technologies
Excel, Power BI, Visio, Smartsheet