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Associate Director Global Product Quality
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Senior Manager / Associate Director – Global Product Quality, Europe
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.
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Requirements
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- 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.
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