Vp Quality - Page Executive

Page Executive; Valencia; Presencial; EUR 140.000 - 190.000; Jornada completa

Descripción de la vacante

Page Executive seeks a VP of Quality to lead the Quality function for a new Valencia manufacturing site. You will shape the Quality strategy, design the QMS, and drive compliance across construction, commissioning, validation and ramp-up while supporting technology transfer and process scale-up.

You will lead cross-functional teams, ensure patient safety, and establish KPIs in a global medical technology environment. This role influences site-level strategy within a global leader.

Formación

• Extensive manufacturing quality leadership experience in medical devices.
• Implantable devices experience preferred (Class III).
• Deep knowledge of global regulatory frameworks (FDA QSR/QMSR, EU MDR 2017/745, ISO 13485, ISO 14971).
• Experience with facility start-up, site expansion or technology transfer.

Responsabilidades

• 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 global health authorities.
• Ensure compliance with applicable international regulatory frameworks.
• Promote a strong quality and compliance culture across the organization.

Conocimientos

Quality leadership

Regulatory compliance

Cross-functional leadership

GMP knowledge

Descripción del empleo

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 global 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