ATMP QA Manager Reading

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.​

Reading

Reading is a large town located at the confluence of the river Thames and the River Kennet in Berkshire, approximately 25 miles from Oxford, 42 miles from London and 17 miles from Basingstoke.   Reading was established in the 8th century as a market town and became prosperous over the following centuries thanks to its cloth, iron works, breweries, bulbs/seed and biscuit industries.  In the 20th century the town continued to expand and is now a significant business centre and home to the UK offices of a significant number of global Pharmaceutical, Life Science and IT companies.   The town has become famous for its annual Reading Festival held over the August Bank Holiday weekend and attended by thousands of music lovers.

Famous people born in Reading: Ricky Gervais (comedian) and Kate Winslet (actress)