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 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.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 Hauppauge’s site's 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 Bachelor’s 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 environmentContamination control, sterilization, sanitation, E-beam; ISO 14644SAP, Oracle, VEEVA, MagicCytiva, 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 atDanaher Benefits Info.The annual salary range for this role is 155,000 - 175,000. 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 Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.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 . Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here.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: or SummaryJob number: R Date posted : Profession: Quality & Regulatory AffairsEmployment type: Full time