Sr. Manager, Quality Excellence

Danaher Corporation•Hauppauge, NY

1d•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 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 the Danaher Business System, which makes everything possible. As the Senior Manager, Quality Excellence you 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.

Requirements

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.
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.
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.
Proven ability to lead, coach, and mentor teams; manage performance; plan succession; and effectively communicate at all organizational levels, both written and verbal.
Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities.
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.

Nice To Haves

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

Responsibilities

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.
Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems support site operations and drive continuous improvement.
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.
Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, physical safety, and continuous improvement.
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.