Cytiva · 2 hours ago
Quality Excellence Manager
Hauppauge, NY
Full-time
Onsite
Mid, Senior Level
$120K/yr - $140K/yr
5+ years expCytiva is a company committed to innovating for tangible impact in life sciences, diagnostics, and biotechnology. The Quality Excellence Manager will lead the Quality team, ensuring compliance with quality management systems and driving continuous improvement while collaborating with cross-functional leadership.
BiotechnologyLife Science
Responsibilities
Serve as the site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality 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 initiatives
Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, and continuous improvement
Lead Quality Management Reviews, define and monitor KPIs, host audits, and represent the site in executive discussions and global best practice initiatives
Qualification
Required
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
Ability to lead, coach, and mentor teams through collaboration & influence; strong written and verbal communication across all organizational levels
Knowledge of ISO 9001/13485 standards, FDA regulations, cGMPs, CFR requirements, and quality systems (CAPA, complaints, change control, audits, risk management)
Skilled in statistical quality methods, Lean principles, Six Sigma, and Root Cause Analysis for data-driven decision-making
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!
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
Preferred
Prior leadership experience preferred
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Cytiva
Cytiva, now with the life sciences business from Pall Corporation, is a global biotechnology leader dedicated to helping customers discover and commercialize the next generation of therapeutics.
10001+ employees
H1B Sponsorship
Cytiva has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (3)
2023 (3)
Funding
Current Stage
Late StageLeadership Team
Christopher Riley
Chief Executive Officer
Hassan A.
Head of Chemistry - Bioprocessing/CTO
Recent News
2025-10-14
Company data provided by crunchbase