Head of Validation

Reporting into the senior Quality leadership team, this is a high-profile position responsible for developing and implementing validation strategies across pharmaceutical manufacturing operations. The successful candidate will oversee validation activities covering aseptic processing, sterilisation, equipment, facilities, utilities and GxP computerised systems.

You will lead and develop a multidisciplinary Validation team while ensuring manufacturing operations remain compliant with current GMP requirements, international regulations and recognised industry standards.

​ Key Responsibilities

• Provide strategic and technical leadership for validation activities across multiple manufacturing sites.

• Develop, implement and continuously improve validation strategies covering:

• Equipment qualification

• Facilities and utilities qualification

• Sterilisation validation

• Aseptic processing validation

• GxP Computerised System Validation

• Ensure validation programmes comply with current GMP, international regulatory requirements and relevant industry standards.

• Lead the development, review and approval of validation policies, procedures, protocols and reports.

• Act as the senior validation subject matter expert during regulatory inspections and customer audits.

• Drive continuous improvement across validation systems, processes and delivery.

• Partner with Engineering, Manufacturing, Quality, IT and Regulatory Affairs on capital projects, equipment installations, facility expansions and system upgrades.

• Provide validation expertise during change control activities.

• Develop validation strategies for new technologies, digital systems and manufacturing improvements.

• Lead, coach and develop the Validation team, including objective setting, succession planning and professional development.

• Identify validation training requirements across the wider business.

• Monitor departmental KPIs, validation schedules, priorities and resources.

• Promote a strong culture of quality, compliance, safety and continuous improvement.

Essential Requirements

• Degree or equivalent qualification in Pharmaceutical Sciences, Engineering, Microbiology, Biotechnology, Chemistry or a related discipline. Candidates with at least 10 years of relevant industry experience may also be considered.

• Significant experience within pharmaceutical or sterile manufacturing environments.

• Strong experience working within GMP-regulated operations.

• Extensive experience leading validation programmes covering equipment, facilities, utilities, sterilisation, aseptic processing and GxP computerised systems.

​

​