Open role
QA & Validation Manager
- Aggregated by CV-Library
- Manchester, Greater Manchester
- Permanent
- Full Time
- £60,000 - £60,000 Per Annum
Job Description
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
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