• Beckman Coulter
  • Danvers , MA
  • Executive Management
  • Full-Time
  • 18 Summer St

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About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps. Our mission of Advancing Cancer Diagnostics, Improving Lives is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com for more information. Leica Biosystems is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check. Be sure to follow Leica Biosystems on LinkedIn!


Thisis a senior management position with quality and regulatory (QRA) leadership responsibilitiesfor the Advanced Staining & Imaging (ASI), the largest and most strategic global business unit of LeicaBiosystems. Provides leadership anddirection through managers and senior professional staff. Is accountable for the performance and resultsof the global QRA team, including all aspects of regulatory affairs (includingstrategies and submissions) quality assurance, quality systems, productquality, and compliance. Serves as abusiness partner who effectively leads QRA while also contributing to the overallsuccess of the operating company. TheQRA leader has a proven track record of strong organizational leadership and buildingeffective multi-site teams in the medical device/IVD regulated industry. Is able and motivated to develop further into roleswith greater responsibility. Ability to develop and drive regulatorystrategies for novel products.


Develop and leadstrategic regulatory and quality initiatives to support growth of the AdvancedStaining & Imaging (ASI) business unit. Integrate strategies across ASI s broad anatomic pathology IVD portfolio(e.g. companion diagnostics, protein staining, molecular methods, digitalimaging and analysis).

Senior leadershipof the ASI quality assurance and regulatory affairs organization across allapplicable sites including: Vista CA,Danvers MA, Newcastle UK, Amsterdam NE, Dublin Ireland, Bangalore India, andMelbourne Australia.

Drives effective collaborations with MedicalAffairs, Clinical Affairs and Scientific Affairs to ensure patient needs andclinical trial objectives are a shared focus leading to scientifically robustand compliant strategies and product approvals.

Is accountable for the performance and resultsof the QRA organization including, but not limited to: compliance, growthinitiatives (i.e. registrations, submissions, supporting clinicals), talent& organizational development, and departmental objectives.

Develops strategies and plans to meet performanceobjectives of the organization.

Effectively delegates initiatives and tasks.

Member of the ASI senior leadership team andreports dotted-line to the ASI Global Vice President.

Member of theLBS QRA management team with responsibilities for tracking and reporting KPIsand driving improvement of performance metrics. Responsible for global QRA initiatives, as assigned.

Lead anddevelop the ASI QRA team according to the Danaher Leadership Anchors (e.g.Charts the Course, Builds Teams, Drives Innovation, Acts with Integrity). Responsible for developing associatesthrough continuous development planning (D4G); drive successful and measurableemployee engagement.

Managetimelines, budgets and resource allocation according to requirements of thebusiness.

Effectively leadthrough Danaher Business System (DBS) tools to drive continuous improvement.

Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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