Commercial Quality and Regulatory Affairs Mgr in Nationwide Italy at Beckman Coulter Diagnostics

Date Posted: 5/8/2018

Job Snapshot

Job Description

Job ID: BEC009635

About Us

At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.

We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.

Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences. 


Summary of Role

Reporting to the Senior Manager - Commercial Q&RA for Europe & Canada, the Manager – Commercial Q&RA Italy will lead all Q&RA activities needed to support Italian commercial operations. The role has direct management responsibility for a small Q&RA Analyst team.

Specific Responsibilities

•  Maintain, implement and continually improve the processes and infrastructure of the Italy region QMS with the purpose of providing both best in class compliance and business support for the Italy Commercial organization

  • Actively recruit, develop and retain talent within the Italy Commercial Q&RA organization

  • Continually develop, monitor and report on the metrics needed to gauge the performance of the Quality System

  • Establish and drive successful fulfillment of Italy Commercial Q&RA objectives; monitor and report on progress to these objectives

  • Support the establishment and fulfillment of Italy Commercial Operations objectives

  • Provide input to the EU Commercial Q&RA budget

  • Liaise with regional and global Q&RA organisation to support the development of and ensure alignment with BEC global policies and procedures

  • Establish and maintain strong and effective working relationships with external parties as necessary for the effective fulfilment of other role responsibilities.

  •  Support the application of DBS tools throughout EU and drive DBS activity within the Italy Commercial Q&RA function

  •  Otherwise support the Italian business and the EU commercial Q&RA department, as required

Job Requirements


  • University Degree in Science or equivalent

  • Lead Auditor trained (ISO 9001)

  • Experience of managing a certificated ISO 9001 Quality Management System

  • Fluent in English – written and verbal

  • Skilled at managing ambiguity, influencing without authority and driving for results

  • Experience of working within a global, multi-cultural, matrix organization

  • Solid working knowledge of IVDD/R and related regulations

  • Deep and current knowledge of Quality Management principles in a European Commercial environment

  • Proven success of building and leading a team, managing and developing talent

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.