Manager QA, EU Qualified Person Cell Therapy
Core
Act as the Qualified Person (QP) to verify and release investigational and commercial Cell Therapy (ATMP) products for EU/EEA and global markets, ensuring compliance with EU GMP and regulatory requirements.
Role type
Manager, Qualified Person (Cell Therapy)
Builds
Investigational and Commercial Advanced Therapy Medicinal Products (ATMPs)
Domain
Biotechnology / Cell Therapy / Pharmaceutical Manufacturing
Required skills
EU Qualified Person certification, GMP/GDP compliance, batch disposition, risk assessment, regulatory interpretation, aseptic manufacturing knowledge, quality investigations, supplier audits
Preferred skills
Experience as Qualified Person, knowledge of autologous cell therapy treatments, negotiation of Quality Agreements
Technologies
GMP/GDP guidelines, EU GMP Vol. 4, MHRA guidelines
Responsibilities
Act as Qualified Person per license requirements; interpret and apply international/regional/local regulations; verify QP certification of imported ATMPs; conduct final review and approval of non-routine quality investigations; participate in GMP/GDP health authority inspections; manage quality and compliance risks; develop and maintain release processes; author and revise procedures and work instructions; participate in GMP audits of suppliers.
Seniority
Manager, hands-on IC