ATMP QA Manager Sittingbourne

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.​

Sittingbourne

Sittingbourne is located in the Swale district of Kent in south east England approximately 45 miles from London, 17 miles from Canterbury, 20 miles from Ashford and 17 from Maidstone.   Sittingbourne has direct railway links to London’s Victoria and St Pancras International stations with a journey time of around one hour and road links, particularly to the coastal ports, are also excellent.  

The main employers in the Sittingbourne area are in the paper manufacture, cement making and fruit farming industries, Kent is particularly famous for its apples and cherries.  In days gone by the Sittingbourne area was also well known for brick making, barge building and water transport.  The Dolphin Sailing Barge Museum provides an insight into the barge building industry.  New industries growing in the Sittingbourne area include engineering, IT, distribution/logistics and life sciences, the latter particular at the Kent Science Park.