Permanent
Multi-site presence required
Key Responsibilities
- Provide QA leadership and approval for all validation activities, ensuring GMP, Annex 1, and MHRA compliance.
- Establish and maintain QA oversight of validation strategy across processes, equipment, utilities, systems, and facilities.
- Act as the primary QA interface for Operations‑led validation, offering independent quality support.
- Review and approve validation plans, protocols, reports, deviations, CAPAs, and change controls.
- Embed validation requirements into QC, NPI, and facility‑based projects across multiple sites.
- Provide QA oversight of sterile and aseptic validation activities, supporting inspection readiness.
- Line manage, coach, and develop a team of four QA validation professionals.
- Drive continuous improvement of validation standards, documentation, and QA–Operations collaboration.
Requirements
- Strong experience in GMP validation within a QA environment.
- Proven background in sterile and aseptic manufacturing.
- Demonstrated experience reviewing and approving validation documentation from a QA perspective.
- Practical experience managing deviations, CAPAs, and change control related to validation.
- People management or significant project leadership experience.
- Willingness and flexibility to travel across multiple UK sites.
- Confident communicator with the ability to influence cross‑functional stakeholders.
- Experience supporting QC, NPI, or facility‑based projects.
- Previous involvement in regulatory inspections (MHRA or equivalent).
- Experience helping to shape or establish QA validation frameworks or governance models.