Description

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

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 practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

The DI and Data Governance Expert is to implement, improve and evolve the Data Integrity and Data Governance Programmes at Barnard Castle. Plays a key role in regulatory (internal/external) audits to answer questions and demonstrate to auditors that the necessary controls and required competencies are in place for GSK Barnard Castle to maintain its licence to operate. Responsible for ensuring operations operates under applicable regulatory policies for documentation and Data Integrity/guidelines and implements/maintains a site governance process (CoP). Performs internal audits on site to ensure the site is audit ready and strict GMP standards are met throughout the manufacturing business units (GMP/GDP).

In this role you will…

• Develop and Lead the Site Data Integrity and Governance Programmes that will meet the requirements of MHRA and other key regulators for data.
  • a. Agree a long-term strategy with key stakeholders and ensure the short-term programme aligns to the long-term vision
  • b. The programme must also align to the data integrity improvement strategy and must ensure that good documentation practices are being applied to all records, both paper and electronic.
  • c. Define scope, schedule and resources for programme and ensure appropriate number of resources is provided.
• Development and implement policies and procedures that align to QMS and regulatory requirements on Data Integrity and Data Governance. These should significantly reduce the potential for Data Integrity issues to occur and improve the sites ability to both detect and prevent data integrity issues.
  • a. Develop training programmes that increase the awareness across the site.
  • b. Develop mechanisms that increase the sites capability to detect issues (e.g. self inspection, speak up).
  • c. Build knowledge of and capability to address and manage DI issues in functional areas as part of improvements.
  • d. Identify and confirm the need for SME's and develop a plan to develop capabilities as required.
  • e. Ensure data integrity requirements are embedded in site cultural and capability programmes on site (e.g. Induction, First Line Leader, through the development of the appropriate training programmes at all organisational levels.
• Develop a prioritised programme to upgrade production and laboratory equipment and systems to comply with regulatory requirements for data. This should include both laboratory and production equipment and be underpinned by a documented robust assessment process and a documented rationale.
• Develop simple tools for assessing laboratory and production documentation for data integrity and identifying gaps through formal assessments and in-process Gembas.
  • a. Develop simple solutions for mitigating these gaps as JDIs or formal projects.
• Manage a multi-functional team of cross-site resources to deliver the programme.
  • a. Lead and mentor a team of workstream leads.
  • b. Where required support the recruitment and onboarding of resources to ensure plans can be delivered.
• Attend, lead and provide input for governance meetings (daily accountability, weekly workstream review meetings, site steering and above-site steering meetings).
• Lead workstream governance meetings (accountability, schedule review, action review, risk management etc) that allow information flow and escalation of issues as part of standard work.
  • a. Identify and manage risks, dependencies, issues and changes and ensure that actions are identified. Escalate when outside agreed parameters.
  • b. Timely and proactive assessment of respective workstream activity pipeline ensuring identification and logging of risks, actions, issues, dependencies, lessons learned, etc
  • c. Provide timely updates on KPIs (KPI Dashboard) and schedule progress in accordance with agreed performance management processes

Why you? 

Basic Qualifications & Skills:

• Science or Engineering degree and/or significant experience in pharmaceutical manufacturing.
• Detailed understanding of the GSK Quality Management System and relevant legislation
• Experience in leading and managing people coupled with a relevant qualification
• Effective organisation, communication, presentation and influencing skills.

Basic 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.

Closing Date for Applications: 14th November 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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