Quality Compliance Lead in Ware

The Quality Compliance Lead is responsible for leading and managing the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies. The role drives proactive compliance strategies and continuous improvement initiatives to ensure inspections readiness including PAIs. The role ensures Quality compliance of product life cycle management, Quality council and oversight of suppliers, third parties, complaints process, documentation management, and periodic product reviews. The Lead, Quality Compliance serves as a key liaison with internal and external stakeholders, including regulatory authorities, to maintain and enhance GSK's reputation for excellence in quality and compliance. The Quality Compliance Lead reports to the Site Quality Director and is part 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 physical sciences, Biology, chemistry, pharmaceutical sciences or a related discipline.
• Experience working in a commercial pharmaceutical manufacturing facility.
• Experience in Product Lifecycle compliance Management activities.
• Experience in performing Quality compliance activities.
• Experience applying current Good Manufacturing Practice (cGMP), U.S. Food and Drug Administration (FDA) regulations, and international regulatory requirements, including ICH Guidelines 8, 9, 10, and 11, as well as Rest‑of‑World (RoW), World Health Organization (WHO), EudraLex, and Eurasian Economic Union (EEU) standards.

Preferred Qualifications

• Experience applying 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 size 6 - 8)
• Strong interpersonal, communication, and leadership abilities; effective in team‑based and multidisciplinary environments (engineering, operations, validation, supply chain, production, Quality Control (QC), finance, and Environmental Health and Safety (EHS)).
• Skilled in prioritization, decision‑making, and executing actions in high‑pressure, deadline‑driven settings.
• Capable of driving change management in complex environments and resolving conflicts constructively.
• Demonstrates initiative and analytical problem‑solving, using data to inform tactical and strategic decisions.
• Flexible, adaptable, and able to build collaboration and teamwork across diverse functional groups.

How to Apply

If this role speaks to your experience and ambitions, please apply now. Share your CV and a short note explaining how your skills match this role and what impact you hope to make. We welcome applicants from all backgrounds and are happy to discuss reasonable adjustments to support you through the selection process.

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.

Why GSK?

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. 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.