ATMP QA Manager South West

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.​

The South West

The South West region is one of the nine official regions of England.  It consists of Gloucestershire, Bristol, Wiltshire, Somerset, Dorset, Devon and Cornwall, including the Isles of Scilly. Major towns and cities in the region include Bristol, Plymouth, Swindon, Gloucester, Cheltenham, Exeter, Bath, Truro and Bournemouth.  Agriculture and Tourism are the major employers in the west of the region which is less prosperous in general than the east of the region, due in part to the better transport links to London enjoyed by the latter.  In Bristol, Swindon and the M4 corridor the economy centres on aeronautics, defence, telecommunications, electronics, technology and IT.   The region is famous for being home to Stonehenge, Glastonbury, the Eden Project and a wealth of stunning beaches and countryside.

Famous people born in the south West:  Ben Ainslie, multiple Olympic sailing gold medallist and Agatha Christie, novelist/crime writer