Quality Compliance Lead

Posted 6 hours 4 minutes ago by GlaxoSmithKline

Permanent
Full Time
Other
Hertfordshire, Ware, United Kingdom, SG111
Job Description
Quality Compliance Lead

GSK is a global biopharmaceutical company dedicated to improving patient health through innovation in medicines and vaccines.

The Role: The Quality Compliance Lead leads and manages the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies.

Key Responsibilities

  • Act as the primary interface for regulatory inspections (PAIs and routine inspections) and audits, ensuring inspection readiness.
  • Ensure compliance with cGMP, GLP and monitor evolving regulatory requirements, updating quality systems accordingly.
  • Work with Senior Leadership to understand regulatory changes, assess risks, and identify appropriate CAPAs.
  • Lead and perform internal and external audit programs, including vendor and supplier audits.
  • Develop and maintain the Supplier Management Process.
  • Oversee document system management and the Quality council process.
  • Manage quality governance processes and compliance activities including periodic product reviews, IQAs/DRAs, compliance metrics, regulatory intelligence, stability, supplier quality, and complaints oversight.
  • Manage the Quality Risk Model, review trends, and identify improvement actions.
  • Drive continuous improvement initiatives across quality systems and processes.
  • Ensure product lifecycle 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 performing Quality compliance activities.
  • Experience applying cGMP, FDA regulations and international regulatory requirements including ICH Guidelines and WHO/EudraLex.

Preferred Qualifications

  • Leadership experience in setting team priorities, coordinating workflow, coaching, and using agile approaches.
  • Strong interpersonal, communication and leadership abilities across multidisciplinary environments.
  • Skilled in prioritization, decision-making, and executing actions in high pressure, deadline driven settings.
  • Capable of driving change management and resolving conflicts constructively.
  • Demonstrates initiative and analytical problem solving, using data to inform decisions.
  • Flexible, adaptable, and able to build collaboration across diverse functional groups.

Closing Date: 19th April 2026

Work Arrangements: On site (weekly 5 days) at Ware, Hertfordshire, UK. Remote or fully home working arrangements are not available.

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, parental status, national origin, age, disability, etc.

If you require adjustments to the recruitment process, contact for assistance.