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.
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.
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
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Head of Quality Validation employer: Walker Cole International
Join a leading global consumer healthcare organisation that values innovation and collaboration, offering a hybrid working model that promotes work-life balance. As a Senior Regulatory Affairs Specialist, you will have the opportunity to take ownership of a diverse portfolio while benefiting from a supportive work culture that prioritises employee growth and development. With a commitment to compliance and quality, this role provides a unique chance to make a meaningful impact in the healthcare sector.
