Global Head of Specialized Quality & Compliance

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

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.