Sr. Manager, Quality Excellence

About the role

At Cytiva, one of Danaher’s 15+ operating companies, you will be part of a team that transforms human health through innovative solutions in life sciences, diagnostics, and biotechnology. This role is based in Hauppauge, New York.

Responsibilities

• 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.
• Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems support site operations and drive continuous improvement.
• 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.
• Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, physical safety, and continuous improvement.
• 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.

Requirements

• 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.
• 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.
• 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.
• Proven ability to lead, coach, and mentor teams; manage performance; plan succession; and effectively communicate at all organizational levels, both written and verbal.
• Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities.

Qualifications

• 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.

Skills

• Quality Leadership & Compliance
• Quality Management System (QMS)
• Strategic Partnership & Advocacy
• Team Development & Performance
• Audits, Reporting, Risk & Representation

Benefits

At Cytiva, we offer a comprehensive benefits package including paid time off, medical/dental/vision insurance, and a 401(k) plan. The annual salary range for this role is $155,000 - $175,000, with the possibility of bonus/incentive pay. For more information, visit www.danaher.com.

Pay

The annual salary range for this role is $155,000 - $175,000.

Schedule

This is an on-site role.