ATMP QA Manager
ATMP QA Managers oversee quality systems specific to Advanced Therapy Medicinal Products (e.g., cell & gene therapies). They ensure all GMP operations meet rigorous regulatory standards and are suitable for highly sensitive, individualized therapies.
Key responsibilities:
Maintaining a comprehensive quality system – Covering deviations, CAPAs, change control, batch release, and documentation.
Leading audits and regulatory inspections – With specific focus on Annex 1, ATMP guidance, and GxP expectations.
Supporting cleanroom and aseptic operations – Ensuring compliance with environmental monitoring, gowning, and contamination control procedures.
Collaborating with manufacturing and QC – To ensure alignment on validation, batch disposition, and product release criteria.
Contributing to regulatory submissions – Supporting Module 3 documentation for ATMP dossiers.
This role is critical in ensuring the safety and consistency of cutting-edge therapeutic products, with deep regulatory and scientific knowledge.