Walker Cole International
Head of Quality Validation
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Head of Quality Validation
Walker Cole International is exclusively partnering with a biotechnology company to find their new Head of Quality Validation. This is a genuinely exciting time to join, with the business investing heavily in a major new GMP manufacturing facility to support the next phase of its pipeline.
As Head of Quality Validation, you'll take ownership of the Quality strategy behind a brand-new manufacturing site - shaping how it's built, qualified and ultimately run, and acting as the key Quality voice throughout a major capital project from the ground up.
The Head of Quality Validation will be:
- Setting the overall Quality approach to how the new site is designed, built, qualified and brought into GMP operation.
- Acting as the go-to Quality partner for the facility project team as it moves from construction into live manufacturing.
- Shaping the site's approach to contamination control and sterility assurance, working alongside specialist SMEs to get it right from day one.
- Overseeing validation of the site's digital and automated systems, ensuring they're compliant and audit-ready from the outset.
- Representing Quality in front of regulators, leading on inspection readiness for everything related to the new site.
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The Head of Quality Validation will have:
- Strong command of GMP regulatory expectations (EU GMP, Annex 1 and Annex 11 in particular), with real experience applying these to a live facility build.
- A track record of leading complex qualification and validation programmes, with a risk-based mindset toward keeping systems in a validated state.
- Genuine depth in contamination control and sterility assurance - comfortable owning strategy, not just executing it.
- Experience representing Quality in regulatory inspections, confident defending validation decisions under scrutiny.
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Key Areas:
- QA Validation
- Facility Qualification
- Contamination Control Strategy
- Sterility Assurance
- ATMP
- Cell & Gene Therapy
- GMP
- Annex 1
- CSV/CSA
- Regulatory Inspection
- Aseptic Manufacturing
- Site Start-Up
- Sterile
- Biopharmaceutical
- Vaccines
ID - 120934
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