ATMP QA Manager Borehamwood

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.​

Borehamwood

Borehamwood is a town in Hertfordshire in the East of England region located approximately 12 miles north east of central London, 7 miles from Watford, 8 from St Albans and 20 from Luton.

Borehamwood’s strategic location with direct access to the M25, M1 and A1M motorways, frequent 18 minutes train service to Charing Cross and excellent connections to Heathrow, Gatwick, Luton and Stansted Airports make it a prime commuter location.  There is, however,

a  wide  range  of  businesses  in Borehamwood with  the creative  industries  and  niche  pharmaceutical companies being particularly well represented.    The world famous Elstree Studios are also located in Borehamwood; popular TV shows that are filmed at Elstree include Holby City, Who Wants to be a Millionaire and East Enders.

Famous people from Borehamwood:  Simon Cowell, reality TV judge and Marilyn, 1980’s “New Romantic” pop singer