Head of Specialized Quality (Clinical, PV & MD)

Page Executive; Barcelona; On-site; EUR 120,000 - 160,000; Full time

Job summary

Page Executive is seeking a Head of Specialized Quality to lead quality strategy across Clinical, Pharmacovigilance and Medical Device domains in an international setting. You will ensure GCP/GVP/MDR compliance, drive quality improvements, and oversee QA systems, inspections and cross-functional collaborations.

The role requires a university life sciences degree, senior leadership experience in regulated sectors, and strong strategic and stakeholder-management skills.

Qualifications

• University degree in Pharmacy, Pharmaceutical Sciences, Medicine, Biology, Biotechnology or similar Life Sciences discipline.
• Significant experience in highly regulated life sciences sectors including 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.
• Ability to operate effectively in international, cross-functional environments.

Responsibilities

• Define and implement the Specialized Quality strategy aligned with global quality objectives.
• Harmonize quality standards across Clinical Quality, Pharmacovigilance, and Medical Device Quality.
• Provide quality oversight of clinical development activities ensuring GCP compliance.
• Support governance of clinical studies, vendors and service providers for inspection readiness.
• Lead the Pharmacovigilance Quality Management System with key stakeholders.
• Drive continuous improvement of PV quality processes including metrics, deviations, CAPAs and inspections.
• Oversee the Medical Device Quality Management System ensuring ISO 13485 and MDR compliance.
• Provide quality leadership for medical devices, combination products, and emerging technologies.
• Act as SME for specialized quality disciplines and contribute to cross-functional initiatives.
• Define and monitor quality performance indicators to drive improvement and operational excellence.
• Lead, coach and develop a specialized quality team with a culture of collaboration and accountability.
• Partner with Regulatory Affairs, R&D, Medical Affairs, Pharmacovigilance and broader Quality functions to support objectives and compliance.
• Represent the organization during inspections, audits and interactions with external stakeholders.

Skills

GCP

GVP

ISO 13485

MDR

Quality leadership

Stakeholder management

Cross-functional collaboration

Regulatory compliance

Strategic planning

Education

Pharmacy degree

Pharmaceutical Sciences

Life sciences

Job description

• International healthcare company
• Head of Specialized Quality

About Our Client

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.

Job Description

• 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.

The Successful Applicant

• 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.