Quality R&D Operations - Validation Lead

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About the role

The validation team based at GSK’s research & development (R&D) site at Ware provide validation expertise across the site to ensure that GMP manufacturing equipment associated with the R&D site is correctly installed and qualified.  We are now looking for a capable validation professional to join the team to support the Quality R&D Small Molecule function (the role reports into the Small Molecule R&D Quality Director). The Quality R&D Operations Validation Lead provides Quality Assurance oversight across GSK’s UK Pharma R&D sites to ensure compliant validation, qualification, and operational quality activities.  The role works across Engineering, Facilities, Validation, R&D Operations, Scientific Functions, and outsourced service providers.  Operating with a high degree of autonomy, you will provide expert guidance and risk-based decision-making on complex quality and compliance matters with regulatory and business impact.   The position influences quality strategy, governance, and inspection readiness, ensuring alignment with GxP requirements, Quality Management System (QMS) expectations, and business aims.  In delivering your role you will act as a key partner to senior stakeholders and operational partners; driving compliance, continuous improvement, and operational excellence while ensuring lifecycle oversight of facilities, utilities, equipment, and computerised systems.   Key areas of validation responsibility include; Equipment, Facilities and Utilities (as well as some focus on associated Computerised Systems / Automation).   Key Responsibilities (include).., •            Manage complex cross-functional QA-related projects and programmes, ensuring delivery against defined scope, timelines, and quality aims (particularly in support of regulatory inspections, high-risk compliance activities, and business-critical initiatives).  This extends to implementing (and improving) QA processes and procedures to drive consistency across R&D. •            Act as a co-ordinator for complex quality initiatives, working with cross-functional stakeholders, tracking progress, managing risks and dependencies, and ensuring successful execution.  This extends to providing quality strategic oversight for business-critical programmes, making risk-based decisions and escalating significant compliance issues to senior management (where appropriate). •            Build strong relationships with internal stakeholders and external partners, acting as a primary contact for designated projects, programmes, or business areas.  This includes managing (or supporting) regulatory inspections and audits (including planning, preparation, execution, and follow-up). •            Drive continuous improvement initiatives to ensure delivery through structured systems (including the provision of clear reporting of project status, risks, and key quality issues to senior stakeholders).   Travel:   Please note that some travel between GSK’s UK R&D sites (Ware R&D, Stevenage, Harlow & Addenbrookes, Cambridge) will be required.     About You: As this role is multi-faceted and includes liaising with a wide variety of on-site teams, you will be a self-motivated person who has experience of working in technical and/or validation roles within a complex working environment (eg; a R&D or manufacturing site).  You will be resilient, with strong people skills and a proven ability to deliver and solve problems.  You will also have a strong continuous improvement mindset.     About GSK: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform peop

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