Job Description

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.
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.

📌 Head of Specialized Quality (Barcelona)
🏢 Page Executive
📍 Barcelona