Quality Director - Cytiva Duncan

Danaher Corporation•Duncan, SC

2d•Onsite

About The Position

As the Quality Director Duncan, you will collaborate closely with cross-functional leadership and associates to ensure compliant execution, monitoring, and continuous improvement of the company QMS in line with certification requirements and customer expectations. This position reports to the Sr Director QA - U&FM and leads both the Quality Control and Quality Assurance teams located in Duncan. This is an on-site role. 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.

Requirements

Hold a Bachelor’s degree, preferably in Science, Business, or Engineering.
Have at least 7 years of experience in Quality Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA/EPA-regulated manufacturing environments.
Possess 5+ years of leadership experience, with senior leadership roles in QA, Operations, or Quality Engineering preferred.
Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including operational controls, CAPA, complaints, audits, and risk management.
Proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, 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.

Responsibilities

Serve as the Duncan 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 customer expectations.
Drive continuous improvement with DBS mindset and in line with the global standards and customer expectations.
Collaborate with site and global leadership to advocate for site-specific needs, drive customer-centric solutions, support change management and change control initiatives.
Build a high-performing quality department, fostering a safe, transparent and empowering environment that encourages skill development, psychological safety, and continuous improvement.
Drive efficiency in site specific quality processes.
Lead Quality Management Reviews for the site, define and monitor KPIs in line with the global guidelines, host audits, and represent the site in executive discussions and global best practice initiatives.