Sr. Manager, Quality Excellence

Cytiva; Hauppauge (NY); On-site; USD 155,000 - 175,000; Full time

Benefits offered by this job

Paid time off

Medical/Dental/Vision insurance

401(k)

Job summary

Cytiva is hiring a Senior Manager, Quality Excellence in Hauppauge, NY, responsible for leading quality control and assurance efforts. This on-site role requires significant experience in regulated environments, strong leadership skills, and the ability to build high-performing teams. Responsibilities include implementing and optimizing the Quality Management System. The annual salary ranges from $155,000 to $175,000, along with bonus potential and comprehensive benefits including medical and 401(k).

Qualifications

• 10+ years of experience within a regulated manufacturing environment.
• At least 7 years of experience in Quality or Quality Engineering.
• 5+ years of leadership experience in related fields.

Responsibilities

• Lead QA/QC, Quality Engineering & Laboratory functions.
• Implement and optimize the Cytiva QMS.
• Build and develop a high-performing quality department.

Skills

Quality Leadership & Compliance

Analytical and Process Optimization

Leadership and Communication

Regulatory and Quality Expertise

Strategic and Operational Acumen

Education

Bachelor’s degree in Science or Engineering

Tools

SAP

Oracle

VEEVA

Job description

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.

What You Will Do

• Quality Leadership & Compliance: Serve as the 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

Benefits & Compensation

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.

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 [e-mail].

Equal Opportunity

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.