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.
Responsabilidades
- Head of Quality for the new site, defining structure, capabilities and strategy
- Design and implement the Quality Management System aligned with integral standards
- Ensure Quality integration across construction, commissioning, validation and start-up activities
- Lead site-wide quality, compliance, risk management and continuous improvement programs
- Drive audit readiness during site development and ramp-up
- Establish and monitor quality KPIs and escalation mechanisms
- Recruit, develop and lead multidisciplinary Quality teams
- Lead regulatory interactions with European and global health authorities
- Ensure compliance with applicable international regulatory frameworks
- Promote a strong quality and compliance culture across the organization
Requisitos principales
- 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