The client is expanding its manufacturing footprint in the Valencia region to develop a new medical technology facility and global production hub over the coming years. The Vice President of Quality will build and lead the Quality function for the newly established manufacturing site, defining the site’s Quality strategy and developing a Quality Management System from the ground up. This role reports into senior global leadership and will integrate Quality and regulatory requirements throughout construction, commissioning, validation, and operational ramp up.
As part of the site leadership team, the Vice President of Quality will support technology transfer, process validation, and manufacturing scale up, while establishing a strong culture of quality, compliance, and continuous improvement. Key responsibilities include acting as Head of Quality for the site, designing and implementing the Quality Management System aligned with global standards, and leading organization-wide quality, compliance, risk management, and continuous improvement programs. The role will ensure audit readiness during site development and ramp up, define and monitor quality performance indicators with escalation mechanisms, and recruit, develop, and lead multidisciplinary Quality teams.
The Vice President of Quality will serve as the primary Quality representative for regulatory interactions related to site approval and ongoing operations, leading engagement with European and global health authorities. The position is expected to ensure compliance with applicable international regulatory frameworks across the full product lifecycle, promote a strong quality and compliance culture, and manage facility start up, site expansion, and technology transfer activities in regulated manufacturing environments. The role requires senior manufacturing Quality leadership with hands-on experience in medical device production settings (ideally implantable medical devices, with preference for Class III products), strong knowledge of global regulatory requirements, direct experience with regulatory authorities and audits, and the ability to lead in complex, matrixed, multicultural organizations.