Quality Excellence Manager

Reposted 16 Hours Ago
Be an Early Applicant
Hauppauge, NY, USA
In-Office
120K-140K Annually
Senior level
Biotech
The Role
The Quality Excellence Manager will lead the Quality Management System implementation, regulatory compliance, team development, and quality initiatives in a life sciences environment.
Summary Generated by Built In

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.

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:

  • 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!

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.

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.

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.

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 www.danaher.com.

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 [email protected].

Top Skills

Fda Regulations
Iso 13485
Iso 9001
Lean Principles
Quality Management System
Risk Management
Six Sigma
Statistical Quality Methods
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The Company
HQ: Sunnyvale, CA
4,883 Employees
Year Founded: 1996

What We Do

Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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