Head Of Validations

We are seeking an experienced and strategic Head of Validations to lead our global validation function across our pharmaceutical manufacturing operations. Reporting to the Director of Quality and R&D, this senior role is responsible for developing and implementing validation strategies for aseptic processing, sterilisation, and equipment qualification across all manufacturing sites. The role is also responsible for overseeing GxP Computerised System Validation activities, ensuring a high-performing Validation team that supports manufacturing operations while maintaining regulatory compliance.

Main Activities/Tasks

• Provide strategic and technical leadership for validation activities across global manufacturing sites.
• Develop, implement and continuously improve the company's validation master strategy for:
  • Equipment qualification
  • Facilities and utilities qualification
  • Sterilisation validation
  • Aseptic processing validation
  • GxP Computer Systems Validation (CSV)
• Ensure validation programmes comply with current GMP, international regulatory requirements and recognised industry standards.
• Lead the development, review and approval of validation policies, procedures, protocols and reports.
• Act as the company Subject Matter Expert (SME) for validation and CSV during regulatory inspections and customer audits.
• Drive continuous improvement of validation systems, ensuring efficient delivery while maintaining compliance.
• Collaborate with Engineering, Manufacturing, Quality, IT and Regulatory Affairs on new capital projects, equipment installations, facility expansions and system upgrades.
• Provide expert input into change control activities to ensure validation requirements are appropriately assessed and executed.
• Develop validation strategies for new technologies, digital systems and manufacturing improvements.
• Identify training needs across the business and deliver or coordinate validation-related training.
• Monitor departmental KPIs, validation schedules and resource planning to ensure projects are delivered on time and in compliance.
• Promote a strong culture of quality, compliance and continuous improvement throughout the organisation.
• Ensure all Health & Safety policies and procedures are followed within the department.
• Participate in wider Quality and business improvement initiatives as required.

Essential Criteria:

• Degree, or equivalent qualification, in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or a related discipline, or at least 10 years relevant industry experience
• Significant experience within the pharmaceutical or sterile manufacturing industry, operating within GMP regulated environments
• Extensive experience leading validation programmes covering equipment, facilities, utilities, sterilisation, aseptic processing and GxP Computer System Validation
• Proven leadership experience manging multidisciplinary technical teams
• Strong working knowledge of US and EU GMP requirements, including EudraLex Annex 1 and Annex 11
• Strong project management and organisational skills with the ability to prioritise multiple projects and deliver to challenging deadlines

Desirable Criteria:

• Experience leading a global or multi-site pharmaceutical validation function
• Knowledge of industry standards for validations such as ISPE. BS/EN, GAMP 5, ASTM etc
• Previous project participation in introducing new equipment facilities and systems, or modification of existing systems
• Participation in EU or US regulatory audits
• Lean Six Sigma or equivalent​​​​​​​

Benefits:

• Free life assurance
• Pension salary sacrifice scheme with 5% employer contribution
• Healthcare cash plan
• 32 days annual leave (increasing with length of service)
• Wedding leave
• Enhanced Maternity / Paternity Pay
• Company Sick Pay
• Subsidised Canteen Facilities
• FREE On-site parking
• Cycle to Work Scheme
• Tech Purchase Scheme
• Free Will-Writing Service
• Employee perks/discounts scheme
• Employee Assistance Programme (EAP)
• Employee well-being initiatives
• Employee recognition scheme