Head of Quality Validation

Walker Cole International; England; On-site; GBP 110,000 - 160,000; Full time

Job summary

Walker Cole International is partnering with a biotechnology company to identify a Head of Quality Validation for a brand-new GMP manufacturing site. You will own the Quality strategy, guiding design, qualification and GMP operation, and serve as the Quality voice on a major capital project from ground up.

The role requires expertise in EU GMP, Annex 1 and Annex 11, plus a proven record of leading complex qualification and validation programmes, with a focus on contamination control and

Qualifications

• Strong command of GMP regulatory expectations (EU GMP, Annex 1 and Annex 11).
• Track record leading complex qualification and validation programmes.
• Depth in contamination control and sterility assurance.

Responsibilities

• Setting the overall Quality approach for the new site from design through GMP operation.
• Acting as the go-to Quality partner for the project team during construction to live manufacturing.
• Shaping contamination control and sterility assurance strategy with SMEs.
• Overseeing validation of digital and automated systems to ensure audit readiness from day one.
• Representing Quality in regulatory inspections and readiness for inspections.

Skills

GMP knowledge

Regulatory inspections

Validation leadership

Contamination control

Job description

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