Senior Director QA - U&FM

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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 that 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.

The Snr Director – U&FM QA  is responsible for leading the Quality function within the HWS OpCo BU partnering with Customers, Product Management, R&D and Operations to meet business objectives and drive longterm growth

This position reports to the VP QARA Hardware Solutions and is part of the Cytiva Bioprocess HWS QA/RA Leadership Team located in Duncan, SC/Medemblik, Netherlands and will be an on-site role. 

What you will do:

• Partners with the BU GM and their Leadership Team, Cytiva QARA leadership and related stakeholders to drive functional initiatives, supportive of the business priorities, enabling the business strategy & growth.
• Collaborate, lead and support customers on both short and long term quality initiatives and escalations acting as the voice of the BU and Cytiva as required
• Responsible for setting & monitoring Quality KPI's including, reporting on performance/ trend insights within business reviews
• Ensure critical business challenges are escalated and addressed and adapt strategic and daily management (DM) plans accordingly
• Lead critical PSP’s and manage PD level activities

Who you are:

• Bachelor's degree and minimum 10+ years’ work experience in a Quality or Regulatory Assurance related field.
• Comprehensive knowledge of Quality Systems, which ensure that products, processes, and services consistently meet or exceed the desired quality standards, including compliance to ISO 9001, ISO 10993, FDA 21 CFR Part 820 and ISO 13485.
• Working knowledge of manufacturing processes, product assembly, materials and properties.
• Demonstrated understanding of root cause analysis, corrective and preventive action (CAPA), change control, verification and validation methodologies, manufacturing/production process control methodologies, risk management, and continuous improvement in a medical device environment.
• Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization.
• Proven Strong leadership skills. With 10+ Yr people leader experience, preferably globally

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel internationally at short notice and up to 50%
• Must have a valid driver’s license with an acceptable driving record
• Ability to be site based and enter and exit cleanrooms/production spaces on a regular basis

It would be a plus if you also possess previous experience in:

• Operations, R&D, Engineering or other related functions. 

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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