QA & Validation Manager

Reporting to the Head of Quality UK, the QA and Validation Manager can be Located at a Choice of Company UK Locations and will have Responsibility for the Quality Assurance Projects Team ROLE * Providing Quality and Validation Leadership, Across Seven UK Licensed Sites, with Accountability for All Site Validations and Consistent Applications of GMP, GDP and MHRA Requirements * Key interface between Quality Assurance, Regulatory Affairs, Operations and Quality Control, Ensuring Consistent Standards, Robust Systems and Inspection Readiness Across the Network * Combining Strategic Oversight with Hands‑On Regulatory Input, Supporting Routine Commercial Operations and Development Programmes * Building and Maintaining Good Working Relationships Across the Sites and Overseeing and Harmonising Validation, Including Deviations, CAPA’s, Change Control, Documentation and Risk Management * Attendance at Global Quality Management Meetings and Tracking Actions to Ensure Timely Closure * Ensure Inspection Readiness and Direct Participation in Client Audits and Inspections by Regulatory Authorities * Act as Advisor to Site Teams in Aspects of Validation, Projects and Quality Continual Improvements * Working Alongside Head of Quality to Implement a New Electronic Document/Quality Management System * Supporting Head of Quality in Driving Continuous Improvement, Inspection Readiness and Quality Culture across UK Network * Act as the QA Validation Lead for Commercial and IMP Activities * Support Regulatory Interactions with MHRA and Other Authorities, Including Inspections, Audits, Responses and Ongoing Compliance Commitments * Provide QA Input to Product Development, Technology Transfer and Validation Activities * Review and Approve Quality and Regulatory Documentation, Including SOP’s, Batch Documentation, Validation Protocols and Development Reports REQUIRED * Degree or Higher in Validation or Equivalent Experience in a Pharmaceutical Setting * Strong Background in Validation, with a Minimum of 5 Years’ Experience * Previous Managerial or Supervisory Experience with a Demonstrable Track Record of Strong Performance * Proven Track Record of Working and Networking Across Multiple Sites and Motivating Teams on Site and Remotely to Implement Consistent Quality Standards at Scale * Proven QA and Validation Experience within Nuclear Medicine, Sterile Manufacturing or Aseptic Processing Environments. * Demonstrable Experience Supporting Commercial and IMP Product Development * Strong Working Knowledge of UK and EU GMP, MHRA Regulatory Requirements and GxP Compliance * Background in Regulatory Inspections, Audits and Authority Interactions within a Licensed Manufacturing Environment * Experience Collaborating Cross‑Functionally with Manufacturing, Quality Control, Development and Clinical Teams * Confident and Capable Communicator, (Spoken and Written), with Ability to Operate at Both Operational and Senior Stakeholder Level * Self-Motivated, Proactive, with Demonstrable Lead by Example Skills * Experienced in Microsoft Windows, Word, Excel and PowerPoint