Head of Quality Validation

Head of Quality Validation

Walker Cole International is exclusively partnering with an advanced therapeutics 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 advanced cell and gene therapy 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