Quality Excellence Manager

Danaher • Hauppauge, NY

2d • 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 Quality Excellence Leader 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 team 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 in Science, preference in Chemistry or Engineering (or equivalent professional experience).
• Have at least 5+ years in Quality Assurance or Quality/Process Engineering within FDA/EPA-regulated environments (Life Sciences, Biotechnology, Medical Device, Biopharma). Including 2+ years in validation and FMEA methodologies.
• Experience with contamination control, cleanroom operations, environmental monitoring, and microbiology preferred.
• Prior leadership experience preferred.
• Ability to lead, coach, and mentor teams through collaboration & influence; strong written and verbal communication across all organizational levels.
• Regulatory & Quality Expertise: Knowledge of ISO 9001/13485 standards, FDA regulations, cGMPs, CFR requirements, and quality systems (CAPA, complaints, change control, audits, risk management).
• Analytical & Process Optimization: Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making.
• Strategic & Operational Acumen: Capacity to manage budgets, evaluate opportunity costs, and drive innovative problem-solving while maintaining exceptional organizational and time management skills.
• Motivated, eager and excited to make a difference!
• 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

• Experience with contamination control, cleanroom operations, environmental monitoring, and microbiology preferred.
• Prior leadership experience preferred.

Responsibilities

• Quality Leadership & Compliance: Serve as the site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality 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 initiatives.
• Team Development & Performance: Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, and continuous improvement.
• Audits, Reporting, & Representation: Lead Quality Management Reviews, define and monitor KPIs, host audits, and represent the site in executive discussions and global best practice initiatives.

Benefits

• Cytiva, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees