ROLE OVERVIEW

This is an exciting opportunity for a Validation Manager to join a growing pharmaceutical manufacturing organisation. Our client is seeking an experienced validation professional to lead and develop a high-performing Validation team responsible for ensuring the compliant validation of facilities, equipment, systems and processes operating within a GMP-regulated environment.

The successful candidate will play a critical role in supporting the organisation's ongoing cGMP compliance strategy by driving validation excellence, continuous improvement and regulatory readiness. This position offers the opportunity to provide technical leadership across validation activities, whilst working closely with Quality, Engineering and Operations teams to ensure compliance with EudraLex Volume 4, including Annex 11 and Annex 15 requirements.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Validation Manager will be varied, however the key duties and responsibilities are as follows:

• Coordinate and perform validation project activities for facilities, equipment, systems and processes in compliance with EudraLex Volume 4 GMP requirements and other applicable quality standards.
• Lead, develop and mentor the Validation team whilst supporting the recruitment, training and performance management of team members.
• Establish and maintain validation procedures, policies, Validation Master Plans (VMPs), SOPs and departmental best practices to ensure ongoing compliance and operational effectiveness.
• Prepare, execute and review validation protocols and reports, ensuring all activities are completed in line with regulatory and company requirements.
• Liaise closely with Engineering, Quality Assurance and User Departments to ensure validation activities are delivered efficiently with minimal disruption to operations and production schedules.
• Drive continuous improvement initiatives by reviewing and rationalising validation documentation, processes and protocol requirements whilst maintaining full regulatory compliance.
• Maintain awareness of regulatory developments and industry best practice, representing the Validation function during internal meetings, customer audits and regulatory inspections.
• Ensure validation procedures, policies, master plans and supporting documentation are reviewed, updated and maintained in line with evolving regulatory expectations.