Quality Systems and DI Lead (Secondment) in Irvine

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024, helping to make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies, including robotics, digital solutions and artificial intelligence, to deliver for patients.

The Quality Systems and DI Lead provides quality system expertise (primarily MERP) and leads the site Data Integrity programme. You will work with Quality, Manufacturing, Engineering and project teams to ensure systems and processes are effective and compliant in supporting Data Integrity for GxP activities. This role is responsible for ensuring delivery of the site Data Integrity Improvement Plan.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Lead the development, maintenance and continuous improvement of the quality management processes within MERP (Manufacturing Enterprise Resource Planning - GSK Configuration of SAP) via proper change management.
• Own site and network data integrity strategy execution, including monitoring, gap closure and improvement plans.
• Support investigations of quality system and data integrity incidents, contribute to root cause analysis and ensure robust corrective and preventive actions.
• Provide M-ERP quality system and data integrity subject matter expertise during audits, regulatory inspections and internal reviews.
• Drive training and capability-building activities to improve how teams use quality systems and handle data across the data lifecycle.
• Collaborate with IT, validation and operations to ensure systems are compliant, validated and maintained in line with quality requirements.

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Degree or equivalent in a scientific, engineering, technical or IT discipline.
• Experience in quality systems, data integrity or quality assurance in a regulated environment.
• Practical experience with GxP quality systems and data integrity expectations.
• Experience leading investigations, root cause analysis and CAPA processes.
• Experience working with electronic quality management systems or validated IT systems.
• Clear written and verbal communication skills in English, with the ability to work with cross-functional teams.

If you have the following characteristics, it would be a plus:

• Experience in the pharmaceutical, biotech or medical device sectors.
• Training or certification in auditing, CSV (computer system validation), or data governance.
• Knowledge of regulatory expectations for data integrity and quality systems (for example MHRA, FDA).
• Experience with metrics, trending and reporting to drive continuous improvement.
• Experience coaching or delivering training to improve quality culture and behaviours.

You will be based in Irvine, Scotland and expected to work on-site to support audits, inspections and close collaboration with site teams. If you are motivated to grow, make a real impact and help improve how we deliver quality for patients, we want to hear from you. Please apply and tell us how your experience meets the qualifications and how you would add value to quality systems and data integrity at GSK. We look forward to learning about you.

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.