Manager QA, EU Qualified Person Cell Therapy
Core
Act as the Qualified Person (QP) to verify and approve the release of investigational and commercial Advanced Therapy Medicinal Products (ATMPs), specifically cell therapies, ensuring compliance with EU GMP and regulatory requirements.
Role type
Manager, Qualified Person (Cell Therapy)
Builds
Approved batches of investigational and commercial cell therapy products for EU/EEA and Rest of World markets.
Domain
Biotechnology / Cell Therapy / Pharmaceutical Manufacturing
Required skills
EU Qualified Person certification, GMP/GDP compliance, batch disposition, risk assessment, regulatory interpretation, aseptic manufacturing knowledge, cell therapy processes, quality investigations, supplier audits
Preferred skills
Experience as a Qualified Person, knowledge of ATMP guidelines (EU GMP Vol 4), negotiation of quality agreements
Technologies
GMP/GDP guidelines, EU GMP Vol 4, MHRA guidelines
Responsibilities
Act as Qualified Person per license requirements and Professional Code of Conduct; Interpret international, regional, and local regulations within the GMP/GDP environment; Perform verification of QP certification for imported ATMPs; Interact with global Quality and Supply Chain functions for batch disposition; Participate in GMP/GDP health authority inspections and corrective actions; Manage quality and compliance risks via risk assessments; Develop and maintain release processes for autologous cell therapies; Conduct final review of non-routine quality investigations; Author and revise procedures and work instructions; Participate in GMP audits of suppliers and service providers.
Seniority
Manager, hands-on IC