AssureBio is proud to partner with a leading UK manufacturer in the search for an experienced Quality Assurance Manager.
This is a key site-based leadership role, representing Quality Assurance at site level and ensuring compliance with GMP and MHRA requirements in the manufacture of life-changing diagnostic and therapeutic products.
As the QA Manager, you’ll play a central role, named as Head of QC for the site, and lead the QA function to maintain, develop, and continually improve the Quality Management System.
The Role
This role is perfect for an experienced Quality professional who thrives in a fast-paced manufacturing environment and enjoys leading people, driving improvement, and influencing cross-functional teams.
* Lead the QA team (QA Officers, Document Controller, and QA Support) and act as the Quality lead on site.
* Oversee all Quality Systems, including deviation management, CAPA, change control, OOS/OOT investigations, validation, and risk management.
* Support implementation and development of eQMS and LIMS systems.
* Represent Quality in cross-functional projects and new product introductions.
* Ensure Data Integrity and Contamination Control strategies are implemented and routinely monitored.
* Lead internal audits, external audits, and site inspection readiness activities.
* Act as a key contact for MHRA inspections and client audits.
* Partner closely with the Head of Quality, Qualified Persons (QPs), and site leadership to drive a culture of continuous improvement.
About You
We’re looking for a hands-on Quality leader with excellent people and technical skills. You’ll be motivated by impact, ensuring patient safety and product quality while supporting your team’s development.
* A degree (or higher) in a relevant scientific discipline.
* At least 5 years’ experience in Quality Assurance within a GMP manufacturing environment (radiopharmaceuticals or pharmaceuticals preferred).
* Prior leadership or supervisory experience.
* Strong working knowledge of MHRA expectations, GMP compliance, and Data Integrity principles.
* A proactive, collaborative mindset, able to influence, mentor, and lead by example.