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 global 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 strategy Design and implement the Quality Management System aligned with global standards Ensure Quality integration across construction, commissioning, validation and start-up activities Lead site-wide quality, compliance, risk management and continuous improvement programs Establish and monitor quality KPIs and escalation mechanisms Recruit,



develop and lead multidisciplinary Quality teams Lead regulatory interactions with European and general health authorities Ensure compliance with applicable international regulatory frameworks Promote a strong quality and compliance culture across the organization Extensive manufacturing quality leadership experience in medical devices Experience 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 transfer Proven track record building, implementing and sustaining robust QMS in operations Experience leading regulatory interactions including FDA inspections and Notified Body audits Solid understanding of GMP and lifecycle regulatory expectations strong leadership in matrixed, multicultural environments ability to build and develop high-performing teams pragmatic and hands-on mindset with strategic thinking Quality Management System design and implementation Regulatory compliance with FDA, EU MDR, ISO standards Process validation and technology transfer

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📌 Vp Quality - Page Executive (Madrid)
🏢 Page Executive
📍 Madrid