QApliance Manager – South East England
About thepanyJoin a global diagnostics manufacturer renowned for its innovation, quality, and impact in the life sciences sector. With a network of modern manufacturing facilities and a growing international footprint, thepany is investing heavily in transformation and continuous improvement. You’ll be part of a collaborative culture that offers clear career progression, training opportunities, and a sharedmitment to improving patient oues.
About the RoleWe’re hiring a QApliance Manager to lead a team focused on maintaining and enhancing the Quality Management System (QMS) inpliance with GMP, ISO 9001, ISO 13485, and other regulatory standards. Reporting to the Head of Quality, you’ll oversee internal audits, batch record reviews, CAPA systems, and customer audits, while also supporting regulatory inspections, training, and change control.This is a senior-level opportunity with potential Qualified Person (QP) sponsorship for the right candidate.
Key Responsibilities:
1. Lead and develop the QApliance team
2. Maintain and improve the QMS in line with EU GMP and ISO standards
3. Oversee internal audits, CAPA management, and batch documentation review
4. Host customer audits and support regulatory inspections
5. Drive continuous improvement and contribute to strategic quality initiatives
6. Support training, change control, andpliance projects
Candidate RequirementsEssential:
7. Degree in a scientific discipline ( Chemistry, Biology, or related field)
8. 10+ years’ experience in GMP-regulated environments
9. Strong leadership and people management skills
10. In-depth knowledge of EU cGMP, ISO 9001, and ISO 13485
11. Experience supporting or conducting batch release under QP supervision
12. Lead Auditor training and a proactive approach to quality improvement
13. Excellentmunication, organisation, and stakeholder engagement skills
Desirable:
14. Experience in diagnostics or medical device manufacturing
15. Familiarity with regulatory inspections ( MHRA, FDA, ISO audits)
What’s on Offer
16. Clear progression pathway with potential QP sponsorship
17. Opportunity to shape quality strategy in a transforming global business