About this opportunity
Original employer descriptionThe Senior Director of International Quality Operation for Beckman Coulter Diagnostics is responsible for comprehensive strategic and operational leadership of a multifunctional team, including managing through other managers and senior leaders (5-8). You will be responsible for leading quality operations and process transformation in product development and production of mature quality management systems that enable associates to better focus on quality for the business. This position requires an innovative leader with a profound understanding of production and new product development in the medical device industry. A comprehensive knowledge of regulatory requirements, design controls and related operational functionals including budgeting, contracting, strategy and personnel/contractor or vendor management. Your leadership will be instrumental in driving continuous improvement, establishing clear expectations, and aligning quality practices across all functions, thereby contributing to the company's competitive advantage and long-term success. The Director of Quality is a highly visible and impactful role for the business and must represent BEC Quality through collaboration and stakeholder management activities.
This position is part of the global Quality, Regulatory and Clinical Affairs team. The specific role will be located in Suzhou, China and will be on site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will lead a International Quality Operations team covering the following sites Suzhou and Shanghai and report to the Vice President of International Quality Operations. If you thrive in a fast paced, senior leadership role and want to work to build a world-class Quality organization—read on.
In this role, you will have the following opportunities:
- Set the vision, strategy, and priorities for a comprehensive quality assurance, quality control, supplier quality, design quality and commercial quality organization at the Development centers, manufacturing sites and commercial office in scope to achieve long-term business objectives that meet and exceed regulatory and industry standards. Provide strategic leadership and accountability across all BEC Dx sites, representing approximately 15% of the global QRC organization. Ensure alignment with the company quality strategy and objectives. Accountable for the performance and results of these teams.
- Build an international quality organization, directing the strategic oversight of plant operations, including both development, manufacturing and commercial activities. Drive continuous performance management, ensuring that all partners not only meet but exceed the highest quality standards and stringent regulatory requirements, thereby safeguarding and enhancing the organization's reputation for excellence. Represent the company during regulatory inspections and audits, ensuring successful outcomes and addressing any findings promptly.
- Negotiate and align key business/quality strategies with functional partners, including the Senior Director of Operations, Directors of Research & Development, the Engineering leadership teams and the commercial leads to ensure that quality considerations are integrated into product development from the initial design phase through to commercialization. Elevate the culture at the development centers, manufacturing sites and commercial organization in scope by fostering a culture centered around the BEC quality policy and impact on patient results. Promote a culture of quality, continuous improvement, and operational excellence throughout the sites.
- Champion the establishment and maintenance of robust quality assurance and control systems to ensure product compliance with the highest internal and external standards. Provide strategic oversight in monitoring quality performance metrics, identifying trends, and driving corrective actions while championing continuous improvement to enhance product quality and reliability. By directing problem solving through your team, drive process improvements and operational efficiencies to enhance product quality and reliability.
- Lead, mentor, and develop a high-performing quality team, through a team of Managers/Senior Managers (5-8), fostering a collaborative and innovative environment that attracts, develops, and retains high-quality employees, and promotes employee engagement, diversity, professional development, and high levels of employee satisfaction.
- As a member of the China DHR Dx Leadership team, you’ll represent quality and coordinate the Quality teams across the different Dx OpCo. In this capacity, you will provide functional perspectives in platform-level discussions and contribute to strengthened alignment, governance, and decision-making across the Diagnostics China organization.
The essential requirements of the job include:
- Bachelor’s degree in a relevant science or technical engineering discipline with 20+ years of experience, or Masters/Doctoral degree with 18+ years’ experience. Related experience includes 6+ years managing people.
- Minimum of 10 years of experience in quality management within the in-vitro diagnostics or medical device industry.
- Demonstrated experience in managing quality functions at an international manufacturing site.
- Strong knowledge of quality assurance, quality control, supplier quality, design quality and commercial quality principles and practices.
- In-depth understanding of regulatory requirements and standards in the in-vitro diagnostics industry.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong communication, interpersonal, and leadership abilities.
- Excellent professional English is mandatory.
- Ability to travel internationally as required.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
