Qualified Person (QP) – Cell Therapy
Core
Certify ATMP Investigational Medicinal Products (IMPs) for EU and UK clinical trials, ensuring GMP compliance, product quality, and patient safety for individualized cell therapy products.
Role type
Qualified Person (QP) for Cell Therapy
Builds
Certified cell therapy products for clinical trials and commercial use
Domain
Biopharmaceuticals / Cell Therapy / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, ATMP/biologics manufacturing knowledge, regulatory inspection support, audit leadership, risk-based quality strategy, deviation assessment, cross-functional collaboration
Preferred skills
Sterile product disposition, CAPA/Change Control management, Cell Therapy regulatory inspections
Technologies
GMP systems, Quality Management Systems
Responsibilities
Certify IMPs for EU/UK trials, act as named QP for legal responsibility, lead audits and inspections, provide EU GMP expertise to US sites, drive continuous improvement, assess deviations and OOS results, provide quality oversight for Amsterdam site
Seniority
Senior, hands-on IC