Head of Specialized Quality (Clinical, PV & MD)

The Head of Specialized Quality will provide strategic leadership and oversight across Clinical Quality, Pharmacovigilance Quality Systems, and Medical Device Quality activities, ensuring compliance with global regulatory requirements and industry standards. The role will act as the organization's center of excellence for specialized quality disciplines, partnering with cross-functional stakeholders.

• International healthcare company
• Head of Specialized Quality

• Define and implement the Specialized Quality strategy in alignment with the company's global quality objectives.
• Establish and maintain harmonized quality standards across Clinical Quality, Pharmacovigilance Quality Systems, and Medical Device Quality.
• Provide quality oversight of clinical development activities, ensuring compliance with applicable Good Clinical Practice (GCP) requirements.
• Support governance of clinical studies, vendors, and service providers, ensuring inspection readiness at all times.
• Lead the Pharmacovigilance Quality Management System in close collaboration with Pharmacovigilance and other key stakeholders.
• Drive continuous improvement of PV quality processes, including quality metrics, deviations, CAPAs, inspections, and regulatory commitments.
• Oversee the Medical Device Quality Management System, ensuring compliance with ISO 13485, MDR, and applicable regulatory requirements.
• Provide quality leadership for medical devices, combination products, and emerging technologies within the organization's portfolio.
• Act as the internal subject matter expert for specialized quality disciplines and contribute to strategic cross-functional initiatives.
• Define and monitor quality performance indicators, driving continuous improvement and operational excellence across the function.
• Lead, coach, and develop a specialized quality team while fostering a strong culture of collaboration, accountability, and quality excellence.
• Partner closely with Regulatory Affairs, R&D, Medical Affairs, Pharmacovigilance, and broader Quality functions to support key business objectives and regulatory compliance.
• Represent the organization during inspections, audits, and interactions with external stakeholders when required.

• University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Biology, Biotechnology, or another relevant Life Sciences discipline.
• Significant experience within the pharmaceutical, biotechnology, medical device, or other highly regulated life sciences sectors, including proven people leadership responsibilities.
• Strong expertise in GCP, GVP, ISO 13485, MDR, and related regulatory frameworks.
• Solid understanding of Clinical Quality, Pharmacovigilance Quality Systems, and Medical Device Quality requirements.
• Experience managing quality systems, regulatory inspections, audits, deviations, CAPAs, and quality risk management activities.
• Demonstrated ability to operate effectively in complex, international, and cross-functional environments.
• Strong leadership, stakeholder management, communication, and influencing skills.
• Strategic mindset combined with scientific rigor and a pragmatic, risk-based approach to decision-making.
• Continuous improvement mindset with the ability to balance compliance requirements, patient safety, and business priorities.