Quality R&D Operations - Validation Lead

GSK; Ware; On-site; GBP 70,000 - 100,000; Full time

Benefits offered by this job

GSK employee benefits

Job summary

GSK is seeking a capable validation professional to join the Quality R&D Small Molecule function at Ware. The role provides QA oversight across UK Pharma R&D sites to ensure validated facilities, utilities and equipment meet GMP/GxP requirements.

You will advise senior stakeholders, drive lifecycle quality and lead risk-based decision-making with impact on compliance and continuous improvement. The position reports to the Small Molecule R&D Quality Director and involves travel across UK R&D

Qualifications

• GMP/GxP knowledge and regulatory expectations for major countries.
• QA oversight of validation/qualification activities for facilities, utilities, equipment.
• Experience working across cross-functional teams in a complex site.

Responsibilities

• Lead complex QA-related projects ensuring scope, timelines and quality goals.
• Provide quality strategic oversight for business-critical programmes and risk decisions.
• Coordinate with stakeholders and manage regulatory inspections and audits.
• Drive continuous improvement with clear status reporting to senior stakeholders.

Education

BSc in Scientific/Engineering

Tools

Computerised systems validation

Job description

Job Summary

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 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). 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 people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more - our approach to R&D: https://www.gsk.com/en-gb/innovation/

CLOSING DATE for applications

Wednesday 28th of October 2026 (COB).

Basic Qualifications

BSc in relevant subject (eg; 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.

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

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 means preventing disease as well as treating it and we aim to impact health at scale. Our culture focused on patients, shareholders and empowerment makes our purpose.

Equal Opportunity Employer statement

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.

Flexible working

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.

Adjustments to process

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at [e-mail] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

Join us

If you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.