Associate Director Global Product Quality

p Senior Manager / Associate Director – Global Product Quality, Europe /p p About the Role /p p A leading global biopharmaceutical organisation is seeking an experienced strong Quality Assurance leader /strong to support the strategic management of its European Quality System. /p p This is a senior role with broad responsibility across strong GMP, GDP, pharmaceutical and medical device quality /strong , 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. /p p Key Responsibilities /p ul li Lead and maintain the European Quality Management System, ensuring compliance with strong GMP, GDP, MDR, ISO 13485 /strong and applicable regulations. /li li Provide strategic quality oversight across European affiliates and outsourced product portfolios. /li li Review and approve strong deviations, CAPAs, change controls, complaints, validation activities and critical quality documentation /strong . /li li Lead preparation for and participation in strong MHRA, EMA and third-party inspections and audits /strong . /li li Support strong QP training /strong , new product introductions and regional regulatory updates. /li li Oversee product complaints, recalls, self-inspections and quality metrics. /li li Provide quality oversight of strong CMOs, vendors and external partners /strong . /li li Support the Responsible Person/PRRC and provide medical device quality expertise. /li li Review and approve documentation relating to strong medical devices and Software as a Medical Device (SaMD) /strong . /li li Partner with Global Quality, Regulatory, Technical Operations and Supply Chain to support product launches and supply continuity. /li li Mentor and develop Quality team members and drive a culture of continuous improvement. /li /ul p Requirements /p ul li strong 10+ years progressive Quality Assurance experience /strong within pharmaceutical, biopharmaceutical or a similarly regulated environment. /li li Strong experience across strong GMP/GDP Quality Systems /strong and ideally medical devices. /li li Eligible and qualified to act as a strong Named Responsible Person (RP) and/or Responsible Person for Import (RPI) /strong under a UK WDA. /li li Willingness to undertake strong QP training /strong , or already progressing towards QP qualification. /li li Strong experience with strong eQMS, CAPA, deviations, change control and complaints /strong . /li li Experience managing strong CMOs, suppliers and outsourced/virtual product portfolios /strong . /li li Proven experience leading strong MHRA/EMA regulatory inspections and third-party audits /strong . /li li Experience working across strong European affiliates /strong and with senior global stakeholders. /li li Knowledge of strong ISO 13485, MDR and medical device/SaMD quality requirements /strong . /li li Strong leadership, stakeholder management and communication skills. /li /ul p br /p