Senior Director, Quality Assurance & Regulatory Compliance

Senior Director, Quality Assurance & Regulatory Compliance

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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. 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.

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.

• 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.
• 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 business requirements.

• 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+…