Site Data Integrity Lead

GSK Barnard Castle is a key secondary manufacturing site with industry 4.0 equipment to support sustained new product introductions and volume increases. The site contributes revenues of approximately $2Bn annually as a key supplier of GSK products.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in‑office work.

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The Data Integrity Site Lead at Barnard Castle is responsible for implementing, enhancing, and evolving the site’s Data Integrity Programme to meet regulatory expectations. This role is pivotal during internal and external audits, providing assurance to auditors that the site has robust controls and the necessary competencies in place to maintain its licence to operate. The Lead ensures that operations comply with all applicable documentation and data integrity regulations and guidelines and oversees the implementation and maintenance of a site-wide governance process (Community of Practice). Additionally, the role includes conducting internal audits to verify audit readiness and uphold strict GMP/GDP standards across all manufacturing business units.

In this role you will…

• Lead the Site Data Integrity Programme by aligning short‑term actions with a long‑term strategy agreed upon with stakeholders, ensuring compliance with MHRA and other regulatory standards, and embedding good documentation practices across all record types.
• Establish and implement robust policies and procedures that align with QMS and regulatory requirements to proactively reduce data integrity risks and enhance detection and prevention capabilities across the site.
• Drive cultural and capability development by embedding data integrity principles into site‑wide training programmes (e.g. Induction, First Line Leader), building awareness, and developing SME capabilities to manage and resolve data integrity issues.
• Upgrade production and laboratory systems through a prioritised programme based on documented assessments and rationale, ensuring equipment meets regulatory data integrity standards.
• Create practical tools and solutions for assessing documentation integrity in labs and production, identifying gaps via formal reviews and Gembas, and resolving issues through JDIs or structured projects.
• Manage and govern programme delivery by leading a cross‑functional team, supporting recruitment, and facilitating governance meetings to monitor progress, escalate issues, and report KPIs and risks effectively.

Why you?

Basic Qualifications & Skills:

• Science or Engineering degree and/or significant experience in pharmaceutical manufacturing.
• Detailed understanding of Quality Management Systems and relevant legislation
• Experience in leading and managing people coupled with a relevant qualification
• Effective organisation, communication, presentation and influencing skills
• Technical knowledge, communication and leadership skills are critical for this position to meet the requirements of the role. Broad knowledge of regulatory standards, registration processes, analytical testing and quality assurance requirements.

Preferred Qualifications & Skills:

• Extensive knowledge of regulatory requirements across highly regulated and emerging markets and ability to explain these and relate them to manufacturing operations.
• Extensive knowledge of the pharmaceutical industry – particular focus on the development and manufacturing of medicinal products.
• Knowledge of computerised systems would be beneficial in the role.
• Project management skills and experience to bring together resources and actions across multiple functions into effective plans and timelines

Closing Date for Applications: 24th September 2025 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

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