Senior Director, Quality Assurance & Regulatory Compliance

Danaher Corporation; North Tyneside; On-site; GBP 120,000 - 160,000; Full time

Job summary

A leading diagnostics company in the UK is seeking a Senior Director of Quality Assurance and Regulatory Compliance to enhance operational excellence and innovation. This role involves partnering closely with senior leaders to align quality strategies with business objectives, ensuring the delivery of high-complexity diagnostics. The ideal candidate has over 15 years of experience in Quality Assurance within the medical device sector and a strong background in managing large teams. This position allows a unique opportunity to drive significant impact in cancer diagnostics through collaborative leadership.

Qualifications

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

Responsibilities

• Develop quality and compliance initiatives for the Advanced Staining Reagents business.
• Drive collaboration with leadership and regulatory affairs.
• Manage performance of the QARC organization.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Cross-functional collaboration

Strategic thinking

Education

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

Advanced degree

Job description

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.

Key Responsibilities

• 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.

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

Qualifications and Experience

• 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 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.
• Bachelor's degree in a scientific, medical, or technical discipline; advanced degree preferred.

Travel and Physical Requirements

• Ability to travel up 20% global travel.

Preferred Experience

• 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.

Company Culture and Mission

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