Senior Manager Quality & Regulatory Affairs in Amsterdam, Netherlands at Leica Biosystems

Date Posted: 4/15/2018

Job Snapshot

Job Description

Job ID: ADV000764

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 Imaging, Inc. 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. 



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Description

Position Summary and Overview



This is a senior management position within Leica’s Amsterdam facility providing functional and organization leadership of the Quality Assurance (QA), Regulatory Affairs (RA) and Quality Control (QC) groups. Provides in depth QRA leadership and business acumen in driving successful growth and compliance of the Amsterdam business.   Leads QRA aspects of cross-site Amsterdam initiatives.  Sustains and grows the Amsterdam product registrations while working in collaboration with Leica global colleagues.



Major Responsibilities



  • Senior management and leadership of the QRA staff and functional activities supporting the growth and compliance of the LBS Amsterdam business.  Management responsibilities for all aspects of Amsterdam QA, RA and QC.

  • Serve as the Amsterdam Quality Management Representative. Maintain compliance of the Amsterdam site to 21 CFR 820, ISO 13485, ISO 9001, CMDR, and Danaher corporate standards.

  • Meet all QRA objectives for product development and registrations. Establish and maintain an effective working relationship with LBS global registration representatives.

  • Responsible for active participation in Amsterdam leadership team in support of site-specific goals and objectives. 

  • Member of the Advanced Staining Business Unit QRA management team with responsibilities for tracking and reporting KPIs and other performance metrics.  Responsible for cross-site QRA initiatives, as assigned.

  • Lead and develop the Amsterdam QRA team according to the Danaher Leadership Anchors (e.g. Charts the Course, Builds Teams, Drives Innovation, Acts with Integrity).   Responsible for developing associates through continuous development planning (D4G); drive successful and measurable employee engagement.

  • Manage QRA timelines, budgets and resource allocation according to requirements of the business.

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

Job Requirements



Qualifications

Required Skills/Experience



  • Bachelor’s degree in science, medical or technical field and 9+ years’ experience with increasing responsibility in medical device QA/RA, or

  • Graduate degree in science, medical or technical field and 7+ years’ experience with increasing responsibility in medical device QA/RA.

  • Related experience includes 4+ years managing people

  • Must have experience managing medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485. 

  • Experience with medical device registrations in global markets (e.g. US, EMEA, Asia Pacific, Latin American).

  • Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable


Competencies



  • Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators.

  • Organized and detail-oriented

  • High level of initiative, self-motivation and energy.

  • Reliable and responsive.

  • Customer focused

  • High level of integrity



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.



At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.