International healthcare company
Head of Specialized Quality
Our client is an international healthcare company focused on improving people's lives through innovation, science, and a strong commitment to patients. Operating in highly regulated environments, the organization is experiencing an important phase of transformation and growth, strengthening its global quality capabilities across multiple therapeutic and technological areas.
Define and implement the Specialized Quality strategy in alignment with the company's integral 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.
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.
Significant experience within the pharmaceutical, biotechnology, medical device, or other highly regulated life sciences sectors, including proven people leadership responsibilities.
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.
Strong leadership, stakeholder management, communication, and influencing skills.
Please apply to discuss the Head Of Specialized Quality role in Barcelona.

📌 Head of Quality Management (Barcelona)
🏢 Sin nombre
📍 Barcelona