QA Validation Manager – UK
Location: Sheffield (with flexibility to travel to other UK sites)
Permanent
Multi-site presence required
We're supporting a growing pharmaceutical manufacturing organisation operating across several UK sites. With expanding commercial and IMP activities, increasing regulatory expectations, and continued investment in facilities and systems, this is a newly created and highly visible role within the Quality leadership team.
As QA Validation Manager, you'll provide quality and validation leadership across all UK operations, with accountability for validation strategy, governance, and inspection readiness. Reporting directly to the Head of Quality UK, you'll act as a key interface between QA, Regulatory Affairs, Operations, QC, and Development, ensuring consistent standards and robust systems across the network.
This role combines strategic oversight with hands‐on QA and validation expertise and is well suited to an experienced validation professional from a sterile/aseptic environment who enjoys working across sites and influencing at both operational and senior levels.
Key Responsibilities
* Provide QA leadership and validation oversight across all UK facilities, ensuring GMP, GDP, and MHRA compliance.
* Act as the QA Validation lead for commercial and IMP activities.
* Serve as a key interface between Quality, Regulatory, Operations, QC, and project teams.
* Review and approve validation documentation, SOPs, batch documentation, protocols, and reports.
* Oversee and harmonise validation activities across multiple sites, including deviations, CAPAs, change control, and risk management.
* Support product development, technology transfer, and validation activities in sterile and aseptic environments.
* Support regulatory inspections and audits, ensuring ongoing inspection readiness across the network.
* Act as a subject matter expert for validation and provide advisory support to site teams.
* Contribute to continuous improvement initiatives and implementation of new quality systems, including electronic QMS solutions.
* Coach, mentor, and support site teams in validation and quality best practice.
Requirements
Essential:
* Strong QA and validation background.
* Proven experience in sterile and aseptic manufacturing.
* Proven knowledge of UK/EU GMP and MHRA regulatory requirements.
* 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.
Desirable:
* 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.