VP Quality
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Perfil buscado (Hombre/Mujer)
The Vice President of Quality will be responsible for building and leading the Quality function of a newly established manufacturing site in Valencia. Reporting into senior global leadership, this individual will define the site Quality strategy, develop the Quality Management System from the ground up, and ensure full integration of Quality and regulatory requirements throughout construction, commissioning, validation, and operational ramp up.As a key member of the site leadership team, the role will support technology transfer, process validation, and manufacturing scale up, while establishing a strong culture of quality, compliance, and continuous improvement. The position will also serve as the primary Quality representative in all regulatory interactions related to site approval and ongoing operations.Key responsibilities include:
Acting as Head of Quality for the new site, defining organizational structure, capabilities, and strategy
Designing and implementing the Quality Management System in alignment with global standards
Ensuring Quality integration across construction, commissioning, validation, and start up activities
Leading site wide quality, compliance, risk management, and continuous improvement programs
Ensuring audit readiness throughout site development and operational ramp up
Establishing and monitoring quality KPIs and escalation mechanisms
Recruiting, developing, and leading multidisciplinary Quality teams
Leading regulatory interactions with European and global health authorities
Ensuring full compliance with applicable international regulatory frameworks
Promoting a strong quality and compliance culture at all levels of the organization
VP of Quality (Medical Device)
Leading organization within the Medical Device industry
This role requires a senior Quality leader with a strong and proven background in manufacturing environments, operating within highly regulated medical device settings. Experience must be rooted in production operations, ideally within implantable medical devices, rather than commercial, distribution, or purely corporate Quality roles.
The successful candidate will demonstrate:
Mandatory Experience Background Extensive experience in manufacturing Quality leadership, within medical device production environments (not distribution or commercial operations)
Proven exposure to implantable medical devices, with strong preference for Class III products
Deep, hands on knowledge of global regulatory frameworks, including FDA QSR/QMSR, EU MDR (2017/745), ISO 13485, ISO 14971, and related international standards
Direct experience supporting facility start up, site expansion, or technology transfer within regulated manufacturing settings
Demonstrated success building, implementing, and sustaining robust Quality Management Systems in operational environments
Significant experience leading and engaging with regulatory authorities, including FDA inspections, Notified Body audits, and local health authorities
Solid understanding of GMP requirements and regulatory expectations across the full product lifecycle, from validation to commercial manufacturingLeadership Personal Attributes Strong, credible leadership within complex, matrixed, and multicultural organizations
Ability to build, develop, and lead high performing Quality teams across QA, QC, Validation, Supplier Quality, and Compliance
Pragmatic, hands on mindset combined with strategic thinking, particularly suited to greenfield manufacturing environments
High level of integrity, resilience, and commitment to patient safety and product quality
Education Credentials Bachelors degree in a scientific or engineering discipline
Fluency in Spanish and English
Advanced degree, Quality certifications, or Six Sigma credentials considered a strong plus
Our client is a global medical technology leader highly specialized medical devices. The organization is expanding its manufacturing footprint in the Valencia region through the development of a new, state of the art facility that will become a strategically significant global production hub over the coming years. xbhjioe
This role offers the opportunity to join a major global organization at a pivotal moment, with the chance to shape the Quality function of a strategically important manufacturing site from its earliest stages.
ISO 13485, ISO 14971