Head of Specialized Quality, Clinical, Pharmacovigilance & Managing Director

The Company is seeking a Head of Specialized Quality to define and implement quality strategy across clinical quality, pharmacovigilance, and medical device quality. The role will establish harmonized standards, oversee clinical development quality and study governance, and maintain inspection readiness. Responsibilities include leading pharmacovigilance and medical device quality systems, driving improvements in metrics, deviations, corrective and preventive actions, audits, and regulatory commitments, and ensuring compliance with applicable requirements. The successful candidate will lead and develop a specialized team, advise on cross-functional initiatives, partner with scientific and regulatory teams, and represent the organization during inspections and audits. Candidates should hold a university degree in pharmacy, medicine, biology, biotechnology, pharmaceutical sciences, or another relevant life sciences discipline. Significant experience in a highly regulated life sciences sector and a record of people leadership are required. Strong expertise in Good Clinical Practice, Good Pharmacovigilance Practice, ISO 13485, medical device regulations, and related frameworks is essential, along with experience managing quality systems, inspections, audits, deviations, corrective and preventive actions, and quality risk. The role also calls for strategic judgment, scientific rigor, a pragmatic risk-based approach, and strong leadership, communication, stakeholder management, and continuous improvement skills.