Senior Director, Quality Assurance & Regulatory Compliance

Danaher - Global; Newcastle upon Tyne; On-site; GBP 100,000 - 140,000; Full time

Job summary

A leading biomedical company in Newcastle upon Tyne is seeking a Senior Director of Quality Assurance and Regulatory Compliance. This role is critical in shaping quality and compliance strategies for a dynamic portfolio of advanced staining assays. The ideal candidate will possess substantial experience in the IVD market, lead diverse teams, and drive operational excellence. This position offers an opportunity to significantly impact the growth and innovation of diagnostic solutions in cancer care.

Qualifications

• 15+ years of experience in medical device Quality Assurance.
• 8+ years of people leadership experience managing diverse teams.
• Proven expertise in the in vitro diagnostics (IVD) market.

Responsibilities

• Develop strategic quality and compliance initiatives.
• Drive collaboration across Business Unit Leadership and regulatory bodies.
• Champion operational excellence and organizational performance improvements.

Skills

Leadership

Regulatory compliance

Strategic planning

Cross-functional collaboration

Education

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

Tools

Quality Management Systems (QMS)

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Leica Biosystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next‑generation, life‑changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System which makes everything possible.

The Senior Director of Quality Assurance and Regulatory Compliance (QARC) for Leica Biosystems is a key leader within the Advanced Staining Reagents (ASR) Business Unit, responsible for shaping and executing a comprehensive quality and compliance strategy that supports innovation and operational excellence across a fast growing portfolio of advanced staining assays, reagents, and companion diagnostics (CDx) positioning LBS as a leading‑edge cancer diagnostics partner.

Partnering closely with senior leaders, the position provides strategic oversight for quality assurance initiatives, regulatory compliance programs, and risk management activities that enable the development and delivery of high‑complexity diagnostics. Acting as a trusted business partner, this leader aligns quality and compliance strategies with business objectives, enabling innovation while safeguarding patient safety and supporting the long‑term success of the ASR and Pharma Services businesses.

The Sr. Director is accountable for the overall performance and results of the Advanced Staining Reagents Quality Assurance & Regulatory Compliance (QARC) organization, including quality assurance, quality systems, product quality, and regulatory compliance. This responsibility spans ensuring regulatory integrity, driving operational excellence, and embedding a culture of quality across the business. To achieve these outcomes, the Sr. Director provides strategic leadership and direction through a team of managers and senior professionals, fostering collaboration, capability development, and continuous improvement.

This position reports to the VP Global Quality Assurance & Regulatory Compliance and is part of the LBS Global QARC Management Team Advanced Staining Reagents Leadership Team located in Newcastle and will be an on‑site role.

In this role, you will have the opportunity to:

• Develop and execute strategic quality and compliance initiatives that enable growth of the Advanced Staining Reagents (ASR) business and integrate across Leica Biosystems’ broader portfolio (e.g., companion diagnostics, molecular methods, and digital imaging).
• Drive cross‑functional collaboration with Business Unit Leadership, Regulatory Affairs, Clinical Affairs, and Medical Affairs to align patient needs and business objectives, ensuring scientifically robust and compliant strategies that accelerate product availability.
• Own accountability for the performance and results of the QARC organization, including compliance, quality systems, product quality, and achievement of departmental objectives. (e.g. on time delivery, issue resolution, robust design reviews), talent & organizational development, and departmental objectives.
• Develop comprehensive strategies and actionable plans to achieve organizational performance objectives, while managing timelines, budgets, and resource allocation. Ensure effective delegation of initiatives and tasks to managers and senior professionals, fostering accountability and timely execution.
• Champion operational excellence and innovation, implementing forward‑looking solutions to enhance quality systems, streamline processes, and improve organizational performance.
• Serve as a key member of the ASR Leadership Team and LBS QARC management team, promoting best practices, driving cross‑site collaboration, and leading global initiatives to improve quality management systems (QMS), track KPIs, and enhance organizational performance; take ownership of other Global QARC duties as assigned
• Provide visionary leadership that fosters a culture of quality, compliance, and continuous improvement, while building organizational capability and developing future leaders.
• Manage timelines, budgets and resource allocation according to requirements of the business.

The essential requirements of the job include:

• Bachelor’s degree in a scientific, medical, or technical discipline; advanced degree preferred.
• 15+ years of progressive experience in medical device Quality Assurance, including demonstrated success leading Quality Assurance or Regulatory Affairs for a complex business unit of $500M+ revenue.
• Minimum 8+ years of people leadership experience, managing large, diverse teams and developing future leaders.
• Proven technical expertise in the in vitro diagnostics (IVD) market and associated technologies, such as protein‑based assays, molecular methods, imaging, and next‑generation platforms.
• Experience in vitro diagnostics, companion diagnostics, or digital imaging strongly preferred; familiarity with global regulatory requirements and essential standards.
• Track record of strategic impact, driving quality and compliance initiatives that enable innovation and business growth in highly regulated environments.
• Exceptional leadership and influencing skills, with the ability to foster collaboration, lead change, and build organizational capability in a dynamic, global setting.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up 20% global travel.

It would be a plus if you also possess previous experience in:

• Leading in a global, dynamic environment and championing organizational change to drive quality and compliance transformation.
• Translating strategic vision into actionable goals, moving strategy to execution and delivering measurable business impact.
• Building strong cross‑functional relationships and influencing stakeholders, including regulators and senior leadership, through exceptional communication and collaboration skills.

Join our winning team today. Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.