ATMP QA Manager Swindon

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.​

Swindon

Swindon is a town in Wiltshire, in the South West region of England.  It is located approximately 35 miles from both Bristol and Reading and 78 miles from London.  Other major towns within reasonable distance include Oxford, Cheltenham and Salisbury.  Swindon is on the main railway line from Bristol to London Paddington and, with an average journey time of only 1 hour to London, it is a major commuter town.  Road connections are also good, thanks to the proximity of the M4 motorway.  Although many residents commute to London, Bristol and other cities, a substantial number of major employers are located in Swindon including engineering firms such as Honda, BMW/Mini and Halcrow as well as W H Smith's HQ and distribution centre and pharmaceutical companies including Patheon, Catalent Pharma Solutions and Vygon (UK) Ltd.   Swindon also has the head office of the National Trust, the UK Space Agency and national Research Councils including the Biotechnology and Biological Sciences Research Council.

Swindon has two major museums; the STEAM Museum which provides a detailed history of the Great Western Railway and the Museum of Computing, it is also home to the Bodleian Library's book depository, which contains 153 miles of bookshelves

Famous people from Swindon:  Billie Piper; actress and Melinda Messenger; glamour model and TV presenter