Senior Manager, Quality Excellence

About the Role As the Senior Manager, Quality Excellence at Cytiva (a Danaher operating company), you will lead the Quality Management functions at the Hauppauge, NY site, ensuring compliant execution and continuous improvement of the QMS in line with certification requirements and customer expectations. This is an on-site role. What You'll Do

• Serve as the Hauppauge site's Quality Management Representative, leading QA/QC, Quality Engineering & Quality Laboratory functions, ensuring regulatory compliance, customer satisfaction and alignment 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. What We're Looking For
• Hold a Bachelor’s degree, preferably in Science or Engineering, with 10+ years of equivalent experience within a regulated manufacturing environment.
• 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.
• Minimum 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 CAPA, complaints, audits, and risk management.
• Analytical and Process Optimization: proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma, 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. Nice to Have
• Analytical chemistry and/or microbiology in an ISO 17025 environment
• Contamination control, sterilization, sanitation, E-beam; ISO 14644
• SAP, Oracle, VEEVA, MagicCytiva Compensation & Benefits
• 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.
• Comprehensive benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
• Check out our benefits at Danaher Benefits Info.