AssureBio is partnering with a UK-based pharmaceutical manufacturer to appoint an experienced Qualified Person (QP) who can also lead QA Operations at site level.
This is a senior, hands-on Quality leadership role with full QP batch certification responsibility, broad GMP oversight, and the opportunity to shape quality culture across operations.
If you're a QP who enjoys being close to manufacturing, documentation, and people, this is a role where your judgement genuinely matters.
As the principal releasing Qualified Person (QP), you will:
* Certify and release finished pharmaceutical products in line with UK/EU GMP
* Provide senior QA oversight across manufacturing, testing, storage, and supply chain
* Lead QA Operations activity including batch documentation review, deviations, CAPAs, change control, and OOS
* Act as a key Quality advisor to senior leadership on product quality, compliance, and inspection readiness
* Support recalls, mock recalls, and regulatory interactions when required
* From a QA Operations leadership perspective, you will:
* Manage and develop a small on-site QA team and coordinate with contract QPs
* Drive GMP standards through gemba walks, training, and QA presence on the shop floor
* Work cross-functionally with QC, Quality Systems, Operations, and Regulatory Affairs
* Maintain inspection readiness for MHRA and customer audits
* Ensure ongoing compliance with Marketing Authorisations and product quality systems
Key experience
* Eligible UK Qualified Person (QP)
* Strong background in QA Operations within pharmaceutical manufacturing
* Experience with non-sterile dosage forms
* Comfortable operating in regulated, fast-paced environments
* Proven ability to lead people, influence cross-functionally, and make risk-based decisions
* Confident communicator with strong documentation and technical writing skills