Quality Validation and CSV Manager

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.

About Barnard Castle: GSK Barnard Castle is a key secondary manufacturing site. We have invested heavily in industry 4.0 state of the art bespoke equipment to support sustained new product introductions and volume increases. As a key supplier of some of GSK’s blockbuster products the site contributes revenues of ~$2Bn annually.

Job Purpose: 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 (include):

• 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.

About You: As this role is multi-faceted 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 of managing a team in a complex, highly‑regulated manufacturing site. People management skills / 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.

Basic Qualifications:

• Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a manufacturing facility within a highly-regulated industry).
• Relevant knowledge/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 (eg; inspection readiness).

Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to:

• 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 programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.