ATMP QA Manager Leighton Buzzard

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.​

Leighton Buzzard is a town in Bedfordshire in the East of England region, lying approximately 15 miles from both Luton and Milton Keynes, 30 from Northampton and 55 from central London.

Leighton Buzzard is the location of Europe’s largest battery, housed in a huge facility where electricity is converted from AC to DC in one room and stored in another room in a trial being undertaken to assess the viability of storing energy so that it can be used during periods of peak demand.  If successful, battery storage could be added to solar, wind and tidal power as alternative sources of energy.  Leighton Buzzard’s other main claim to fame is the Leighton Buzzard Light Railway, a narrow gauge heritage railway.  The main employment sectors in the Leighton Buzzard area include engineering quarrying.

Famous people from Leighton Buzzard:  Kajagoogoo, 1980’s pop band and Mary Norton, writer author of “The Borrowers” and “Bedknobs and Broomsticks”