Sr. Manager, Quality Excellence

Bring more to life.

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

At Cytiva 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.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people who care for each other our customers and their patients. Take your next step to an altogether life-changing career.

Learn about theDanaher Business System which makes everything possible.

As theSenior Manager Quality Excellenceyou will collaborate closely with cross-functional leadership and associates to ensure compliant execution monitoring and continuous improvement of the implemented QMS in line with certification requirements and customer expectations.

This position reports to the Quality Director Filtration Membrane Sites and leads the Quality Control Quality Assurance and Quality Laboratory teams located in Hauppauge New York. This is an on-site role. At Cytiva our vision is to advance future therapeutics from discovery to delivery.

What you will do:

• Quality Leadership & Compliance: Serve as the Hauppauges sites Quality Management Representative leading QA/QC Quality Engineering & Quality Laboratory functions ensuring regulatory compliance customer satisfaction and aligning with organizational goals.
• Quality Management System (QMS): Implement maintain and optimize the Cytiva QMS ensuring procedures work instructions and IT systems support site operations and drive continuous improvement.
• Strategic Partnership & Advocacy: Collaborate with site and global leadership to address process changes advocate for site-specific needs and drive customer-centric solutions during change management and product development initiatives.
• Team Development & Performance: Build a high-performing quality department fostering a safe empowering environment that encourages skill development psychological safety physical safety and continuous improvement.
• Audits Reporting Risk & Representation: Lead Quality Management Reviews define and monitor KPIs host audits lead risk assessments and represent the site in executive discussions and global best practice initiatives.

Who you are:

• Hold a Bachelors degree preferably in Science or Engineering or 10 years of equivalent experience within a regulated manufacturing environment.
• Have at least 7 years of experience in Quality Quality Engineering or Manufacturing Operations within Life Sciences Biotechnology Medical Device Biopharma or other FDA/EPA-regulated manufacturing environments.
• Possess a minimum of 5 years of leadership experience with 2 years leading both Quality Engineering and Quality Laboratory preferred.
• Regulatory and Quality Expertise: Strong knowledge of ISO 9001 & ISO 13485 standards FDA regulations cGMPs CFR requirements and quality management practices including operational controls validation CAPA complaints audits and risk management.
• Analytical and Process Optimization: Proficiency in quality statistical methods Lean Manufacturing principles Six Sigma methodologies test schedules Gage R&R and Root Cause Analysis tools to drive data-driven decisions and resource optimization.
• Leadership and Communication: Proven ability to lead coach and mentor teams; manage performance; plan succession; and effectively communicate at all organizational levels both written and verbal.
• Strategic and Operational Acumen: Skilled in managing budgets assessing opportunity costs and fostering innovative problem-solving while maintaining exceptional organizational and time management capabilities.

Travel Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel 10% of the time to other Cytiva manufacturing locations in the US and Worldwide as required.
• Ability to access gauges and equipment 5-6 feet off the ground lift and move 20-35 lb. parcels.

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

• Analytical chemistry and/or microbiology in an ISO 17025 environment
• Contamination control sterilization sanitation E-beam; ISO 14644
• SAP Oracle VEEVA Magic

Cytiva 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 atDanaher Benefits Info.

The annual salary range for this role is 155000 - 175000. 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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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .