QA Compliance Specialist

Be part of something altogether life-changing!

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. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The QA Compliance Specialist for Cytiva is responsible for handling all Quality Systems questionnaires and responsible for the local Quality System in our global document management system.

This position is part of the Quality Assurance department  located in Medemblik, the Netherlands and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

• In this role you will be leading the Customer Audits, handling all Quality Systems questionnaires and responsible for the local Quality System in our global document management system. Your main areas of responsibility are divided in approximately 30% customer audits and 70% Quality Systems activities.
• The QA Compliance Specialist is keeping oversight of quality compliance activities (internal and external) and managing the metrics and KPI related to this.
• The QA Compliance Specialist maintaining the overview of the certified state of products, processes, methods and equipment. He / She is handling deviations of any kind.

• The QA Compliance Specialist is the Quality Lead in plant wide compliance projects

The essential requirements of the job include

• Degree: Master in a scientific field, preferable in Lifesciences (bio, biomedical, chemical, pharma,…)
• Experience: 3+ years
• Language: English (written & spoken), Dutch
• Strong working knowledge of quality assurance principles and practices, industry and international regulations and standard, you are familiar with ISO9001 and ISO13485,
• Strong verbal and communications skills, Ability to multitask, problem solve and decision making

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

• Customer communication
• Internal and or externa audits
• QMS

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, 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.