Associate Director Global Product Quality

About the Role

A leading global biopharmaceutical organisation is seeking an experienced Quality Assurance leader to support the strategic management of its European Quality System.

This is a senior role with broad responsibility across GMP, GDP, pharmaceutical and medical device quality
, working closely with senior leadership and European affiliates to ensure regulatory compliance, product quality and patient safety. The role will also play a key part in continuous improvement, product launches, inspections and quality oversight of outsourced operations.

• Lead and maintain the European Quality Management System, ensuring compliance with GMP, GDP, MDR, ISO 13485 and applicable regulations.
• Provide strategic quality oversight across European affiliates and outsourced product portfolios.
• Review and approve deviations, CAPAs, change controls, complaints, validation activities and critical quality documentation
  .
• Lead preparation for and participation in MHRA, EMA and third-party inspections and audits
  .
• Support QP training
  , new product introductions and regional regulatory updates.
• Oversee product complaints, recalls, self-inspections and quality metrics.
• Provide quality oversight of CMOs, vendors and external partners
  .
• Support the Responsible Person/PRRC and provide medical device quality expertise.
• Review and approve documentation relating to medical devices and Software as a Medical Device (SaMD).
• Partner with Global Quality, Regulatory, Technical Operations and Supply Chain to support product launches and supply continuity.
• Mentor and develop Quality team members and drive a culture of continuous improvement.

• 10+ years' progressive Quality Assurance experience within pharmaceutical, biopharmaceutical or a similarly regulated environment.
• Strong experience across GMP/GDP Quality Systems and ideally medical devices.
• Eligible and qualified to act as a Named Responsible Person (RP) and/or Responsible Person for Import (RPI) under a UK WDA.
• Willingness to undertake QP training
  , or already progressing towards QP qualification.
• Strong experience with eQMS, CAPA, deviations, change control and complaints
  .
• Experience managing CMOs, suppliers and outsourced/virtual product portfolios
  .
• Proven experience leading MHRA/EMA regulatory inspections and third-party audits
  .
• Experience working across European affiliates and with senior global stakeholders.
• Knowledge of ISO 13485, MDR and medical device/SaMD quality requirements
  .
• Strong leadership, stakeholder management and communication skills.