Senior Director Quality Operations

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Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 laboratorys 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 makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency clinical confidence adaptive collaboration and accelerated intelligence.

Learn about theDanaher Business Systemwhich makes everything possible.

The Senior Director Quality Operations Clinical Chemistry Immunoassay (CCIA) North America provides seniorlevel operational quality leadership for the Chaska Minnesota and San Diego California manufacturing and development sites with accountability for manufacturing quality and development quality. This role translates enterprise quality strategy into disciplined site execution ensures regulatory compliance and drives a strong culture of quality across CCIA through close partnership with Operations R&D Supply Chain and Regulatory Affairs.

This position reports to the Vice President US Quality Operations and is a key member of the North America Quality Operations leadership team and will be based out of Chaska Minnesota.

In this role you will have the opportunity to:

• Provide strategic and operational quality leadership for the Chaska site and Carlsbad sites driving a strong culture of quality across the CCIA organization and establishing followership through influence and matrixed collaboration with crossfunctional partners.

• Lead and be accountable for a complex multidisciplinary quality organization including Quality Assurance Quality Control Process Validation Design Quality Incoming Inspection and sustained deployment of the Danaher Business System (DBS) to drive standard work problem solving and continuous improvement.

• Ensure sustained compliance with the Quality Management System (QMS) and applicable regulatory requirements partnering with global and local stakeholders to standardize simplify and continuously improve quality processes.

• Own site quality performance and key performance indicators proactively identifying gaps and leading structured problemsolving to resolution when performance is at risk.

• Build and sustain an effective quality organization by ensuring appropriate staffing levels clear role design capability depth succession coverage and overseeing budget allocations required to consistently meet site performance compliance and delivery commitments.

• Build mentor and develop strong diverse teams and quality leaders fostering engagement accountability and leadership behaviors that inspire followership and ownership at all levels of the organization.

• Collaborate across all organizational levels functions and management chains to align priorities communicate risk and drive timely decisions to solution that protect patient safety and ensure the delivery of safe compliant highquality diagnostic products.

The essential requirements of the job include:

• Bachelors degree in a scientific or engineering discipline with 20 years of experience or Masters/Doctoral degree with 18 years of experience including 6 years of people leadership experience.

• Minimum of 10 years of quality leadership experience with invitro diagnostics or medical device industry with direct accountability for manufacturing and/or development quality.

• Demonstrated experience leading quality organizations at multisite or complex manufacturing environments including responsibility for compliance inspections and operational performance.

• Deep working knowledge of quality assurance quality control process validation design quality and supplier/incoming quality within regulated industries.

• Strong understanding of IVD regulatory requirements and quality standards (e.g. FDA ISO global regulatory frameworks).

• Proven ability to lead structured problem solving apply data and riskbased decision making and drive sustainable corrective actions.

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 35% domestically and internationally per business needs.

It would be a plus if you also possess previous experience in:

• Leading regulatory inspections audits or remediation activities in a regulated diagnostics or medical device environment.

• Applying DBS or similar continuous improvement systems to improve quality performance and simplify processes.

• Supporting new product introductions or product transfers partnering with R&D and Operations to ensure compliant commercialization.

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Beckman Coulter Diagnostics a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $230000 - $250000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.

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