Quality Systems and Data Lead in Barnard Castle

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Barnard Castle Manufacturing Site. The Quality function at GSK plays a critical role in ensuring our products meet the highest standards of safety, efficacy, and compliance. As part of this team you will uphold our commitment to delivering high-quality medicines and vaccines, and healthcare products to patients and consumers around the world.

Job Purpose: Reporting into the site’s Quality Director, The Quality Systems and Data Lead is responsible for the effective management, oversight, and continuous improvement of the site’s Quality Management Systems (QMS) and associated data processes. This role ensures compliance with regulatory requirements, drives data integrity, and fosters a culture of quality excellence across the Barnard Castle site.

Direct Reports: The role manages approximately 9 direct reports.

Key Responsibilities:

• Manage and oversee the site’s Quality Management System (QMS) processes to ensure compliance with GMP standards, as well as providing expertise to drive system effectiveness.
• Manage governance and implementation of robust Data Integrity (DI) practices for accuracy, security, and alignment with regulatory requirements.
• Drive innovation in quality systems through digital tools and technologies. This entails working closely with Quality Digital Innovation Experts to streamline processes and improve efficiency.
• Provide oversight and expert guidance on the development, management, and tracking of CAPAs and deviations to ensure timely resolution (as well as continuous improvement).
• Ensure training compliance across the site by designing, delivering, and monitoring effective training programs (maintaining quality standards and regulatory alignment).
• Develop and maintain quality documentation systems for regulatory compliance, accessibility and continuous improvement by collaboration with Documentation Compliance Experts.
• Coordinate cross-functional efforts to enhance quality systems, integrating digital innovation initiatives and data governance frameworks.
• Manage and develop a high-performing team of experts and specialists (providing clarity on roles and responsibilities, as well as succession planning and continuous skill enhancement).
• Foster collaboration across departments, functions and processes (e.g., QMS, DI, CAPA, training, documentation and digital innovation functions) to align with site and above-site quality objectives.
• Act as primary liaison for quality systems audits and inspections to ensure readiness and provide expertise across functional areas (under the Quality Systems and Data Lead scope).

About You: As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in regulatory or quality functions and/or manufacturing at a complex highly-regulated manufacturing site. You should be able to demonstrate knowledge/experience of inspection readiness (audit-experience). You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

Basic Qualifications:

• Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly-regulated industry).
• Management experience.
• Knowledge of current Good Manufacturing Practice (cGMP) requirements.
• Knowledge and application of Quality Management Systems (QMS).
• Knowledge of internal and external audit processes (e.g., inspection readiness).

Benefits: GSK offers a range of benefits to its employees, which include, but are not limited to:

• Competitive base Salary.
• Annual bonus based on company performance.
• Opportunities to partake in on the job training courses.
• Opportunities to attend and partake in industry conferences.
• Opportunities for support for professional development and chartership.
• Access to healthcare and wellbeing programmes.
• Employee recognition programmes.

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

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.