Quality Compliance Director in Ware

GSK remains committed to achieving bold commercial ambitions for the future. By 2031, we aim to deliver £40 billion in annual sales, leveraging our existing strong performance momentum to significantly increase our positive impact on the health of billions of patients globally. Our Ahead Together strategy is centred on early intervention to prevent and alter the course of disease, thereby protecting people and supporting healthcare systems. Our diverse portfolio consists of vaccines, specialty medicines, and general medicines. Through continuous innovation and a dedicated focus on scientific and technical excellence, we strive to develop and launch new, groundbreaking treatments that address critical health challenges.

The Quality Compliance Director is accountable for leading and overseeing the site Quality Compliance function, ensuring sustained adherence to regulatory requirements, GxP standards, and the Quality Management System (QMS). The role drives proactive compliance strategies and continuous improvement initiatives to maintain a high state of inspection readiness, including for Pre‑Approval Inspections (PAIs). The position provides quality governance across the product lifecycle, including Quality Council leadership, oversight of suppliers and third parties, complaints management, documentation control, and Periodic Product Reviews. Acting as a key interface with internal and external stakeholders — including regulatory authorities — the Quality Compliance Director plays a critical role in safeguarding and strengthening GSK’s reputation for excellence in quality and compliance. The Quality Compliance Director reports to the Site Quality Director and is a core member of the site Quality Leadership Team (QLT).

Key Responsibilities

• Act as the primary interface for regulatory inspections (Pre‑Approval Inspections (PAI) and routine inspections) and audits, ensuring inspection readiness.
• Manage and host the regulatory inspections, including preparation, execution, and follow‑up on corrective and preventive actions (CAPAs).
• Ensure compliance with current Good Manufacturing Practices (cGMP), and Good Laboratory Practices (GLP) across all areas.
• Monitor evolving regulatory requirements (e.g., U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organization (WHO) etc.) and ensure timely updates to quality systems and processes.
• Accountable for working with Senior Leadership Team (SLT) to grow capability in understanding Regulatory changes, associated risks and identifying appropriate CAPA.
• Lead and perform internal and external audit programs, including vendors and suppliers’ audits, to assess compliance with GSK standards and regulatory expectations.
• Accountable to develop and maintain the Supplier Management Process.
• Accountable document system management and oversight, Accountable for the Quality council process.
• Ensure the Quality council process effectively drives the improvements and compliance on site.
• Responsible for managing site Quality governance processes and compliance activities including but not limited to Periodic product reviews, Internal Quality Audits (IQA) / Data Review Assessments (DRAs), compliance metrics, Quality Regulatory Intelligence, Stability, Supplier Quality management and Complaints oversight.
• Manage Quality Risk Model (QRM), review trends for all risk elements and identify improvement actions.
• Drive continuous improvement initiatives across quality systems, processes, and culture to enhance compliance and operational efficiency.
• The role ensures Quality product life cycle management and medical device compliance.

Basic Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Physical Sciences, or a related scientific discipline; advanced degree preferred.
• Significant experience within commercial pharmaceutical manufacturing environments, with strong exposure to GMP‑regulated operations and quality systems.
• Demonstrated expertise in Product Lifecycle Compliance Management, including oversight of compliance strategies across product development, commercialization, and post‑market activities.
• Proven experience leading Quality Compliance programs, including deviation management, CAPA effectiveness, audit readiness, inspection support, risk management, and continuous improvement initiatives.
• Deep working knowledge of global regulatory and compliance requirements, including current Good Manufacturing Practices (cGMP), U.S. FDA regulations, ICH Guidelines (Q8, Q9, Q10, Q11), WHO standards, EudraLex, EEU regulations, and other international/Rest‑of‑World requirements.
• Strong leadership experience managing and developing high‑performing quality or compliance teams (approximately 6–8 direct reports), with a demonstrated ability to set clear priorities, drive accountability, develop talent, and lead through change and ambiguity.

Preferred Qualifications

• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence across multidisciplinary functions including Operations, Engineering, Validation, Supply Chain, Production, QC, Finance, and EHS.
• Strong decision‑making and prioritization skills, with the ability to perform effectively under pressure and manage competing business‑critical priorities.
• Proven success leading change management initiatives within complex pharmaceutical or highly regulated environments.
• Strong analytical and strategic problem‑solving capabilities, with the ability to leverage data and metrics to support risk‑based decisions and continuous improvement.
• Highly adaptable and collaborative leadership style, with demonstrated success working across global, diverse, and cross‑functional teams.

Closing Date for Applications – 24th May 2026 EOD

Work Arrangements: 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, 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.