Senior Director, Quality Assurance & Regulatory Compliance (Relocation required)
Do you want to shape the quality and regulatory strategy behind life-changing cancer diagnostics?
Are you ready to lead a global Quality Assurance and Regulatory Compliance organisation within a highly regulated diagnostics environment?
Do you enjoy driving operational excellence, innovation, and compliance across complex global product portfolios?
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.
Our client is seeking a strategic leader to oversee Quality Assurance and Regulatory Compliance activities across a growing portfolio of advanced diagnostic products and companion diagnostics.
Discover more about our Senior Director, Quality Assurance & Regulatory Compliance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Senior Director, Quality Assurance & Regulatory Compliance, you will be measured against the following 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.
What you will do:
As the Senior Director, Quality Assurance & Regulatory Compliance, your duties and responsibilities will include:
· 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.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Director, Quality Assurance & Regulatory Compliance:
· 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.
Got what it takes?
To apply for the Senior Director, Quality Assurance & Regulatory Compliance, click the ‘Apply’ button below or contact the Executive Search Consultant – (REECE WIGGINS) – on +44 (0)203 355 7050.
Please Note:
· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required
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