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Job Description

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.

Responsibilities

As the principal releasing 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

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