GSK
Site Data Integrity Lead
Job Function:
Job Type:
Location:
United Kingdom
Based:
County Durham - Barnard Castle
Closing date:
24th September 2025
ABOUT THE ROLE
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.
REQUIREMENTS
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
ABOUT THE COMPANY
HOW TO APPLY
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.
