Associate Director Global Product Quality

Meet Life Sciences; Windsor; On-site; GBP 90,000 - 130,000; Full time

Job summary

Meet Life Sciences is seeking a senior Quality Assurance leader in the United Kingdom to manage European Quality System strategy and ensure regulatory compliance across GMP, GDP, MDR and ISO 13485. The role collaborates with European affiliates, senior leadership, and outsourced operations to drive quality and patient safety.

The candidate will lead inspections, CAPA processes, changes controls, and QP progression while mentoring the quality team and driving continuous improvement across product

Qualifications

• 10+ years' progressive QA experience in pharma or regulated environment.
• Strong GMP/GDP quality systems experience; medical devices is a plus.
• Eligible to act as Named RP and/or RP for Import under UK WDA; QP training encouraged.
• Experience with eQMS, CAPA, deviations, change control and complaints.
• Experience managing CMOs, suppliers and outsourced portfolios.
• Proven experience leading MHRA/EMA regulatory inspections and third-party audits.

Responsibilities

• Lead and maintain the European Quality Management System, ensuring compliance with GMP, GDP, MDR, ISO 13485.
• 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 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.

Skills

Quality Assurance

GMP/GDP

Leadership

Regulatory inspections

Stakeholder management

Communication

Medical devices quality

Job description

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.

Key Responsibilities

• 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.

Requirements

• 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.