Validation & Projects QA Manager

Reporting to the Head of Quality UK, the Validation & Projects QA 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