ATMP QA Manager Bolton

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.​

Bolton

Bolton is a town in north-west England approximately 10 miles from Manchester.   During the Industrial Revolution Bolton grew from a small cotton and wool weaving  town to a large textile manufacturing centre during the Industrial Revolution with over 200 cotton mills at its peak.  In recent times heavy industry has largely been replaced by service industries such as data processing, call centres, electronics, life sciences and IT.  Bolton has a number of museums, theatres and other attractions including brewery tours, heritage trails, shops, local produce markets, a good range of shops.  The West Pennine Moors are within easy reach for walking and cycling.

Famous people born in Bolton:  Amir Kahn , boxer and Peter Kaye, comedian