Sr. Program Manager (Clinical Chemistry & Immunoassay, Quality, Regulatory)

Danaher•Minneapolis, MN

38d•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Senior Program Manager is responsible for directing all phases of their program(s) within Clinical Chemistry & Immunoassay product lines, with a focus on compliance-based initiatives. This position reports to the Senior Director Program Management Clinical Chemistry & Immunoassay, is part of the CCIA Program Management Team located in Chaska, Minnesota and will be an on-site role. In this role, you will have the opportunity to: Drive high-impact, business-critical programs utilizing Danaher Business System (DBS) tools and methodologies to ensure operational excellence in efficiency, quality, budget, schedule and resource optimization to achieve Quality, Cost, and Delivery (QCD) objectives. Lead, mentor and develop high-performing teams through shared purpose and project goals-leveraging advanced leadership, communication, influence, cross-cultural awareness, negotiation, and conflict resolution skills to consistently meet objectives. Foster robust cross-functional collaboration with key stakeholders across Manufacturing, Engineering, Research & Development, Quality, Regulatory, Marketing, and other functional groups to ensure seamless program execution. Leverage deep expertise in Quality Management Systems (QMS) to proficiently navigate regulatory landscapes and achieve critical business objectives. Develop and implement robust compliance program strategies, ensuring comprehensive alignment with evolving regulatory requirements.

Requirements

Bachelor's degree in Life Science, Engineering, or related field with preference for 14 plus years of relevant experience or a Master's degree with preference for 12+ years' experience
Prefer 5 years of related work experience in scientific or engineering field; Prefer a minimum of 2-5 years in program or project management.
Strong motivational leadership and executive communication skills with the ability to influence others without direct authority.
Ability to travel (domestic and internationally) up to 20% of time.

Nice To Haves

2-5 years in a quality or regulatory role with in-depth knowledge of ISO standards, particularly in a medical device setting. Direct audit experience is a plus.
Engaging and collaborating with regulatory bodies pre- and post-market (e.g. FDA, BSI, etc.)
Immunoassay and/or Clinical Chemistry diagnostic products; familiarity with consumables, packaging, and labeling is a plus

Responsibilities

Drive high-impact, business-critical programs utilizing Danaher Business System (DBS) tools and methodologies to ensure operational excellence in efficiency, quality, budget, schedule and resource optimization to achieve Quality, Cost, and Delivery (QCD) objectives.
Lead, mentor and develop high-performing teams through shared purpose and project goals-leveraging advanced leadership, communication, influence, cross-cultural awareness, negotiation, and conflict resolution skills to consistently meet objectives.
Foster robust cross-functional collaboration with key stakeholders across Manufacturing, Engineering, Research & Development, Quality, Regulatory, Marketing, and other functional groups to ensure seamless program execution.
Leverage deep expertise in Quality Management Systems (QMS) to proficiently navigate regulatory landscapes and achieve critical business objectives.
Develop and implement robust compliance program strategies, ensuring comprehensive alignment with evolving regulatory requirements.

Benefits

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

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