As VP of Quality, you will lead the Quality function for a new Valencia manufacturing site, shaping the site’s Quality strategy and building the Quality Management System from scratch. You will integrate quality and regulatory requirements across construction, commissioning, validation, and ramp-up, while supporting technology transfer and process scale-up. You will lead cross-functional teams, drive compliance, and establish a culture focused on patient safety and continuous improvement. This role offers strategic influence at site level within a integral medical technology leader and a chance to set the foundation for a pivotal production hub.Head of Quality for the new site, defining structure, capabilities and strategyDesign and implement the Quality Management System aligned with global standardsEnsure Quality integration across construction, commissioning, validation and start-up activitiesLead site-wide quality, compliance, risk management and continuous improvement programsEstablish and monitor quality KPIs and escalation mechanismsRecruit,
develop and lead multidisciplinary Quality teamsLead regulatory interactions with European and global health authoritiesEnsure compliance with applicable international regulatory frameworksPromote a strong quality and compliance culture across the organizationExtensive manufacturing quality leadership experience in medical devicesExperience with implantable devices preferred (Class III)Deep knowledge of global regulatory frameworks (FDA QSR/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971)Direct experience supporting facility start-up, site expansion or technology transferProven track record building, implementing and sustaining robust QMS in operationsExperience leading regulatory interactions including FDA inspections and Notified Body auditsSolid understanding of GMP and lifecycle regulatory expectationsstrong leadership in matrixed, multicultural environmentsability to build and develop high-performing teamspragmatic and hands-on mindset with strategic thinkingQuality Management System design and implementationRegulatory compliance with FDA, EU MDR, ISO standardsProcess validation and technology transfer#J-18808-Ljbffr