Description
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.
Key areas of validation responsibility include; Equipment, Facilities and Utilities (as well as some focus on associated Computerised Systems / Automation).
Key Responsibilities:
- 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).
- Act as a co-ordinator for complex quality initiatives, working with cross-functional stakeholders, tracking progress, managing risks and dependencies, and ensuring successful execution.
- Build strong relationships with internal stakeholders and external partners, acting as a primary contact for designated projects, programmes, or business areas.
- Drive continuous improvement initiatives to ensure delivery through structured systems.
Travel: 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 (e.g. a R&D or manufacturing site).
Basic Qualifications:
- BSc in relevant subject (e.g. Scientific, Technical or Engineering discipline) or equivalent.
- Relevant experience in Quality Assurance (QA) within a GMP-regulated pharmaceutical, biotechnology, or healthcare environment.
- Strong knowledge of GMP/GxP requirements and regulatory expectations for major countries.
- Proven experience providing quality oversight of validation and qualification activities for facilities, utilities, and equipment.
Preferred Qualifications:
- Experience of computerised systems validation would be helpful.
- Understanding of the application of phase appropriate GMP standards would be useful.