Site Data Integrity Lead

Overview

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.

Responsibilities

• 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.
• Provide, maintain and enforce positions on data integrity during audits, ensuring readiness and compliance with GMP/GDP standards across all manufacturing units.

Qualifications

• 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 GSK Barnard Castle & Benefits

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 offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programmes. 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. We are an Equal Opportunity Employer and strive to create an environment where our people can thrive. We encourage you to explore opportunities with our hiring team. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) Open Payments data page and our Life at GSK webpage for benefits and culture details.