Senior Quality Validation & CSV Lead in Barnard Castle

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.

Direct Reports

The role manages approximately 9 to 12 direct reports.

Key Responsibilities

• Manage the planning, execution, and maintenance of validation activities (process, cleaning, facility, computer systems, 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 (Engineering, Manufacturing, IT, and Quality) to align validation activities 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 (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.
• Support the adoption of new technologies, methods, and equipment by integrating validation requirements 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.

About You

As this role is multi‑faceted and involves liaising with a wide variety of on‑site production and operations teams, you will be a self‑motivated person with strong experience managing a team in a complex, highly regulated manufacturing site. People‑management skills and experience are a pre‑requisite. You will be resilient and calm under pressure, with strong interpersonal skills and a proven ability to influence people to achieve objectives and drive performance. You will possess a 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 while maintaining regulatory and quality compliance. Effective written and verbal communication and organisational skills are essential.

Basic Qualifications

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

Benefits

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

Equal Opportunity Employer

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK provides reasonable accommodation for qualified applicants with disabilities and other special circumstances and encourages applicants who require assistance to contact its Adjustments team at UKRecruitment.Adjustments@gsk.com for assistance.