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Senior Director Commercial Quality and Regulatory Affairs in Buffalo Grove, Illinois at Leica Biosystems

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job ID: COR001358

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  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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This is a senior management position with quality and regulatory (QRA) leadership responsibilities across Leica’s commercial entities (i.e. sales units).  Provides leadership and direction through managers and senior professional staff.   Is accountable for the performance and results of the organization including, but not limited to, effectiveness of registrations and compliance of quality system(s).  Acts as a business partner to the sales units and a communication channel between sales units and business units for QRA matters.

Major Responsibilities 
  • Senior leadership of the commercial (SU) QRA organization across the Americas, China, Asia-Pacific, and EMEA.  
  • Accountable for the performance and results related to the roles and responsibilities of the organization, including: compliance, registrations, relationships with regulators, and effective communications across Leica sales units and business units.
  • Develops strategies and plans to meet performance objectives of the organization.  Effectively delegates initiatives and tasks.
  • Member of the LBS QRAC management team with responsibilities for tracking and reporting KPIs and other performance metrics.  Responsible for global QRAC initiatives, as assigned.
  • Lead and develop the Commercial 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 timelines, budgets and resource allocation according to requirements of the business.
  • Effectively use Danaher Business System (DBS) tools to drive continuous improvement.

Job Requirements


  • Bachelor’s degree in science, medical or technical field and 15+ years’ experience with increasing responsibility in medical device QA/RA, or 
  • Graduate degree in science, medical or technical field and 10+ years’ experience with increasing responsibility in medical device QA/RA.
  • Related experience includes 8+ years managing people in a global environment
  • 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. EMEA, Asia Pacific, Latin American).
  • Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable

  • Proven ability to lead global organizations and drive performance.
  • 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

Travel % of Travel, include approximate overnight stays per week
  • Travel expectations for this role is medium (25-35%)

  • This role is global.  Home office should be at one of Leica’s global SU sites.   

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.