Quality Director - Cytiva Duncan

About the role

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. Working at Cytiva means being at the forefront of providing new solutions to transform human health.

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.

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.

Qualifications

• Ability to travel 10% of the time to other Cytiva locations Worldwide, as required.

Skills

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

Benefits

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

Pay

Details on pay are not specified in this posting.

Schedule

The schedule for this role is not specified in this posting.

Additional Information

For more information, visit www.danaher.com. 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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.