Qualified Person (QP) & QA Operations Manager

AssureBio; Greater London; On-site; GBP 60,000 - 80,000; Full time

Job summary

A prominent pharmaceutical company in the UK seeks an experienced Qualified Person (QP) to lead QA Operations on-site. This senior role involves full QP batch certification, GMP oversight, and the chance to influence quality culture in production. Responsibilities include certifying finished products, overseeing QA operations, and leading a small QA team while ensuring compliance and readiness for audits. Ideal candidates will have a strong background in QA within the pharmaceutical sector and excellent communication skills.

Qualifications

• Strong background in QA Operations within pharmaceutical manufacturing.
• Experience with non-sterile dosage forms.
• Comfortable operating in regulated, fast-paced environments.

Responsibilities

• Certify and release finished pharmaceutical products in line with UK / EU GMP.
• Provide senior QA oversight across manufacturing, testing, storage, and supply chain.
• Manage and develop a small on-site QA team.

Skills

Quality Assurance Operations leadership

Risk-based decision-making

Strong communication skills

Technical writing

GMP standards adherence

Education

Eligible UK Qualified Person (QP)

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