Sr. Manager, Quality Excellence

Danaher

Hauppauge, New York

JOB DETAILS
SALARY
$155,000–$175,000 Per Year
SKILLS
Alliance/Partner Management, Analysis Skills, Analytical Chemistry, Auditing, Best Practices, Biology, Biotech and Pharmaceutical, Budget Management, Business Solutions, Change Management, Coaching, Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cost Analysis, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Satisfaction, Environmental Protection Agency (EPA), Environmental Regulations, FDA (Food and Drug Administration), FDA Requirements, Human Health, ISO (International Organization for Standardization), ISO 9001, Information Technology & Information Systems, Leadership, Lean Manufacturing, Lift/Move 20 Pounds, Lift/Move 35 Pounds, Maintain Compliance, Manufacturing, Manufacturing Methods, Manufacturing Operations, Medical Equipment, Medical Products, Mentoring, Microbiology, Operational Strategy, Oracle, Performance Management, Performance Metrics, Problem Solving Skills, Process Improvement, Product Development, Product Programs, Psychology, Quality Assurance, Quality Control, Quality Engineering, Quality Management, Regulations, Risk, Risk Analysis, Risk Management, Root Cause Analysis, SAP, Sanitation, Six Sigma, Sterilization, Succession Planning, System Operations, Systems Administration/Management, Team Building, Technical Support, Test Plan/Schedule, Time Management, Vaccination, Willing to Travel
LOCATION
Hauppauge, New York
POSTED
30+ days ago

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.

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 environment
  • Contamination control, sterilization, sanitation, E-beam; ISO 14644
  • SAP, Oracle, VEEVA, Magic

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 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 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

applyassistance@danaher.com

.

About the Company

D

Danaher

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Computer/IT Services
WEBSITE
https://www.danaher.com/