Senior Director, Quality Assurance & Regulatory ComplianceDanaher Corporation • North Shields, England, United Kingdom
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Senior Director, Quality Assurance & Regulatory Compliance
Danaher Corporation
- North Shields, England, United Kingdom
- North Shields, England, United Kingdom
À propos
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.
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Compétences linguistiques
- English
Avis aux utilisateurs
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