Danaher Corporation Senior Manager - Quality & Regulatory Affairs, East Asia and Oceania (Open) in United States
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Summary of Role
Reporting to the Global VP Q&RA for Commercial Operations, the Senior Manager – Commercial Q&RA will lead the Commercial Q&RA function in support of all EAO commercial operations. The role has direct management responsibility for 7 staff based in different locations throughout the region. The role will have a permanent seat on the EAO leadership team and require 20-40% travel.
• Continually develop the EAO Commercial Quality systems and infrastructure to ensure continued, high quality support for EAO Commercial Operations
- Actively recruit, develop and retain talent within the EAO Commercial Q&RA organisation
Continually develop, monitor and report on the metrics needed to gauge the performance of the EAO Quality System
• Maintain and continually improve the quality processes needed to support the EAO Commercial Q&RA organisation
• Establish and drive successful fulfillment of EAO Commercial Q&RA objectives ; monitor and report on progress to these objectives.
• Support the establishment and fulfillment of EAO Commercial Operations objectives
• Set and monitor performance to the EAO Commercial Q&RA budget
• Sustain and continually improve the EAO multi-site ISO9001 Quality Management Systems – manage the relationship with the Notified Body for each EAO site
• Liaise with the global Q&RA organisation to support the development of and ensure alignment with BEC global policies and procedures
- Provide detailed and up to date regulatory intelligence for the EAO region through maintenance of an external advocacy network and other data sources as appropriate
- Support the application of DBS tools throughout EAO and drive DBS activity within the EAO Commercial Q&RA function
Person Spec – Minimum Requirements
• University Degree in Science or equivalent
• 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 organisation
• Solid working knowledge of EAO IVD and related regulations
• Solid working knowledge of Lean Six Sigma principles
• Deep and current knowledge of Quality Management principles in a Commercial environment
• Proven success of building and leading a team 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 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.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: Asia Pacific-Southeast Asia-Singapore
Req ID: BEC008312