Quality Validation & CSV Leader — Manufacturing

Job description

At the GSK Barnard Castle Manufacturing Site, the Quality function ensures quality and regulatory compliance across the entire product lifecycle within manufacturing and production operations. Quality is central to guaranteeing our medicines meet the highest standards of safety and efficacy. As a member of this team you will help uphold our commitment to delivering safe, effective and compliant products to patients and consumers worldwide.

As Quality Validation and CSV Manager you will manage a team responsible for quality and validation activities, including process and cleaning validation, equipment qualification, facility validation, and Computer Systems Validation (CSV). This role ensures all validation operations comply with regulatory requirements, GSK quality standards (Quality Management System – QMS), and industry best practice.

The role manages approximately 9 to 12 direct reports.

• Manage the planning, execution and maintenance of validation activities (including process, cleaning, facility and Computer Systems Validation, and equipment qualification).
• Ensure validation activities comply with regulatory expectations, GSK quality standards (QMS) and industry best practices, maintaining audit readiness at all times.
• Provide technical expertise for validation and CSV processes.
• Collaborate with cross‑functional teams (including Engineering, Manufacturing, IT and Quality teams) to ensure validation activities align with project timelines and business objectives.
• Develop, review and approve validation protocols, reports and associated documentation, ensuring accuracy, compliance and adherence to validation requirements.
• Manage the validation lifecycle for computer systems (including planning, testing, installation qualification, operational qualification and performance qualification – IQ/OQ/PQ).
• Represent validation activities for internal and external audits, presenting validation strategies and documentation to regulators and auditors to ensure successful outcomes.
• Support the adoption of new technologies, methods and equipment by ensuring validation requirements are integrated seamlessly into development and implementation plans.
• Provide training, development, mentoring and coaching to team members and stakeholders to build site‑wide understanding and capability in validation and CSV practices.

As this role is multi‑faced and includes liaising with a wide variety of on‑site production and operations teams, you will be a self‑motivated person who has strong experience managing a team in a complex, highly‑regulated manufacturing site. People management skills and experience is a pre‑requisite for delivery in the role. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance.

You will have a strong continuous improvement mindset and apply agile thinking and ways of working – iterative problem solving, adaptive planning and prioritisation – to accelerate improvements across cross‑functional teams, whilst maintaining regulatory and quality compliance. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

• Degree in a relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a manufacturing facility within a highly-regulated industry).
• Relevant knowledge and experience within Validation and CSV.
• Leadership experience.
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Knowledge of and application of Quality Management Systems (QMS).
• Knowledge of internal and external audit processes (e.g. inspection readiness).

• Competitive base salary
• Annual bonus based on company performance
• Opportunities to partake in on‑the‑job training courses
• Opportunities to attend and partake in industry conferences
• Opportunities for support for professional development and chartership
• Access to healthcare and wellbeing programmes
• Employee recognition…