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QA & Validation Manager

Job Posted: 24 days ago

Salary: £ 60,000 - 60,000 / Annum
Job Type: Permanent
Location: Manchester, Greater Manchester

Expire in: 3 days

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

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