The Quality Systems & Data Lead provides leadership to a team of Quality professionals critical in overseeing data integrity and governance, training compliance, Quality Management System (QMS) deployment and enhancement, and defining and driving the site Quality Improvement Plan including the role of quality in smart manufacturing. The role also includes responsibility for driving GPS for Quality, Quality Culture and embedding digital innovation and strategy into the site. The role ensures inspection readiness in the area of accountability. The Quality Systems & Data Lead reports to the Site Quality Director and is part of the site Quality Leadership Team (QLT).
Responsibilities
* Lead and drive the Quality digital strategy with site and central functions.
* Provide leadership for site Data Integrity & Governance, ensuring accurate documentation management, secure archiving, retention, and controlled access.
* Apply Lean Six Sigma and GSK Production System (GPS) methods to deliver systemic quality improvements.
* Ensure full training compliance, maintain updated training records, and facilitate required programs.
* Oversee local implementation of updates to quality digital systems VQMS (Vaccines Quality Management System) and MERP (Manufacturing Execution & Reporting Platform) via proper change management.
* Develop, implement, and monitor the Quality Improvement Plan, ensuring continuous improvement.
* Partner with cross‑functional teams to align and integrate quality systems and maintain the QMS (Quality Management Systems).
* Maintain up‑to‑date knowledge of compliance, FDA (Food and Drug Administration) regulations, and industry trends; interpret requirements and embed them into site quality systems.
* Actively contribute to the Quality Leadership Team (QLT) on quality strategy, objectives, and central initiatives.
* Drive Quality Culture and GPS tools such as GEMBA, Process Confirmation, and 5S within Quality.
* Ensure electronic systems are compliant, robust, and sustain data integrity requirements.
Qualifications
* Bachelor’s degree in Life Sciences or a related discipline.
* Experience working in a commercial pharmaceutical manufacturing facility.
* Experience working with quality systems, including validation, compliance, and operations involving high‑volume, rapid‑turnaround workflows, as well as experience applying industry and scientific practices relevant to the business.
* Experience leading improvement programmes that include setting programme objectives, coordinating cross‑functional activities, and tracking implementation outcomes.
* Experience applying Good Manufacturing Practice (GMP) requirements, National Institutes of Health (NIH) guidelines, FDA regulations, and other regulatory agency expectations related to validation, operations, analytical testing, and stability programmes.
* Experience applying GSK leadership expectations by setting team priorities, coordinating workflow to maintain focus, carrying out defined development activities such as coaching or feedback sessions, practicing self‑awareness in daily interactions, and using agile and culturally adaptable approaches when managing tasks or projects. (Team 10‑12, 4 direct reports)
* Strong interpersonal and leadership skills. Solid team player able to function within a team‑based organisation.
* Drive change management in a complex environment.
* Able to interact with peers, subordinates and senior personnel in a multidisciplinary environment including engineering, facility operations, validation, supply chain operations, production, QC, finance and EHS.
* Able to prioritise and decide appropriate course of actions.
* Effective at implementing decisions.
This role offers an on‑site (weekly 5 days) working model at Ware, Hertfordshire, UK. Remote or fully home‑working arrangements are not available for this role.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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