Global Senior Director, Quality&Regulatory Excellence, Dublin Pike

Senior Director, Quality Assurance&Regulatory Compliance (Relocation required) Fraser Dove International is partnering exclusively with a global cancer diagnostics organisation. Operating internationally, they are committed to advancing diagnostic innovation that improves patient outcomes and accelerates access to life‑changing therapies.

Objectives

Drive quality assurance and regulatory compliance strategies that support innovation, operational excellence, and business growth across the diagnostics portfolio.

Strengthen quality management systems (QMS), governance, and compliance performance while maintaining regulatory integrity and product quality standards.

Build and develop a high‑performing quality organisation that promotes collaboration, accountability, continuous improvement, and future leadership capability.

Responsibilities

Develop and execute strategic quality and compliance initiatives across advanced diagnostics and companion diagnostic products.

Partner with senior leaders across Regulatory Affairs, Clinical Affairs, Medical Affairs, and operational teams to align quality objectives with business priorities.

Lead and oversee Quality Assurance and Regulatory Compliance performance, including quality systems, product quality, issue resolution, and compliance activities.

Drive operational excellence through continuous improvement initiatives, process optimisation, and forward‑looking quality strategies.

Provide leadership across global quality management initiatives, including KPI tracking, governance, and cross‑site collaboration activities.

Manage departmental budgets, resource allocation, timelines, and organisational priorities to support business objectives.

Develop and mentor managers and senior professionals, fostering a culture of quality, compliance, innovation, and accountability.

Qualifications

15+ years of progressive experience within medical device, diagnostics, or in‑vitro diagnostics (IVD) quality assurance environments.

Proven leadership experience managing large, complex quality or regulatory organisations within highly regulated global businesses.

Strong experience leading quality and compliance initiatives that enable innovation, operational excellence, and business growth.

Deep technical knowledge of diagnostic technologies including molecular methods, protein‑based assays, imaging, and companion diagnostics.

Exceptional communication, stakeholder management, and influencing skills across global cross‑functional teams and senior leadership groups.

Bachelor’s degree in a scientific, medical, or technical discipline.

Advanced degree or postgraduate qualification preferred.

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