Senior Operations Quality Manager

Our client, a specialist contract manufacturer in the advanced therapies space, is looking for aSenior Quality Operations Manager to lead their Quality Operations team through the next phase of growth.

This is a genuinely broad, senior role. You'll run a large team, hold real authority over how quality operates day to day, and deputise for the Head of QA so you'll need to be someone who's comfortable owning decisions, not just implementing them.

What you'll be doing

You'll lead the team responsible for the operational side of Quality making sure the workload is realistic, the targets are hit, and the GMP standards behind every batch are never in question.

Day to day, that means:

• Keeping the leadership team informed with regular reporting
• Building and interrogating KPIs
• Running the internal audit programme and leading third party responses
• Reviewing protocols, batch records, SOPs and quality events
• Building risk-based audit plans, following them through, and making sure CAPAs actually close out properly
• Leading investigations when things go wrong, root cause, CAPA, and helping operational teams put it right
• Managing your team: hiring, developing and coaching

What we're looking for

• Senior quality leadership experience, ideally gained running a sizeable team in a regulated manufacturing environment
• Strong working knowledge of GMP as it applies to cell therapy or other biological products, sterile, cell-based processing experience is a real advantage
• A solid grounding in biological systems
• Comfortable working in an electronic QMS
• Excellent communication skills
• Honours degree in a life sciences subject, or equivalent experience