Principle Quality Assurance Process 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  Principle Quality Assurance Process Specialist for Cytiva is responsible for key global quality processes with specific focus on end-to-end Change Control process that drive significant impact to the organization.

This position is part of the Quality Governance Team located in Amersham or Uppsala and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

• Leadership of the end-to-end QMS change control process, providing subject matter expertise to all sites and global functions.

• Drive the standardisation & best practise of the QMS change control process across all sites and functions, covering all aspects of the product life cycle management and compliance.

• Ownership and accountability for key global change controls concerning the QMS or major quality related changes. To include leadership of the Global Cross Functional Review Team.

• Working with the DBS tools, to improve effectiveness and efficiency of other key quality processes as required, in line with the customer expectations

• Ownership of the KPI replated to Change Controls, specific to on time completion and effectiveness check. Prepare reports on KPI, identify trends and improvement opportunities

Who you are:

• Bachelor's Degree, or equivalent experience in regulated medical device, pharmaceutical or life sciences industry

• Quality Assurance/ Quality Engineering experience in a GMP environment

• Demonstrated good collaboration skills and expertise to effectively communicate the organization

• Understanding QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001 

• Exceptional analytical, problem solving & root-cause analysis skills as well as proven track record working cross – functionally and at global level

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

• Comprehensive understanding of electronic systems, Magic and Veeva, used to manage change control processes.

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.