Quality Excellence Leader

• Cytiva

About Cytiva

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.

At Cytiva, our vision is to advance future therapeutics from discovery to delivery.

Position Overview

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.

What You Will Do

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.

Who You Are

Education & Experience

• 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.

Skills & Competencies

• 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!

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.

Compensation & Benefits

The annual salary range for this role is $120,000 - $140,000. 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.

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. 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.

Check out our benefits at Danaher Benefits Info.

Equal Opportunity & Accommodations

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: 1-202-419-7762 or applyassistance@danaher.com.

About Danaher

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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