QA Leader- Enterprise Solutions

Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry 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.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are looking for a QA Manager (EMEA region) to work with our expert Enterprise Solutions team of over 800 employees across the world. Do you have expertise in Quality Assurance and a passion for working with Global teams on Customer Projects? Then we would love to hear from you!
What you’ll do
This position will be the principal Enterprise Solutions (ES) QA leader for the EMEA region supporting customer ES projects. You will be required to support QA activities onsite at customer facilities, as required.
Main responsibilities include:


Accountable for monitoring & supporting the continuous Improvement of the Quality Management System (QMS) supporting the EMEA ES team.
Execution of QA responsibilities associated with document control, change control, deviation, Field Action, complaint & CAPA management, and responding to customer feedback.
Participate in the establishment of equipment testing documents for ES Flex Factory (FF) products.
Coordinate qualification documentation, validation protocols and reports from draft to approval.
Accountable for ensuring fulfillment of requests from the Customer Quality Assurance organization.
Conduct trainings, such as GDP, GMP (21 CFR part 210/211, part 820) and document control, to the ES project team, as necessary.
Responsible for internal escalation and categorization of risks associated with ES project teams’ interactions with customers, third parties and regulators.
Support coordination and oversight of KUBio Qualification.
Domestic and/or international travel to support FF and KUBio project on-site qualification document control, including but not limit to, documents from SAT, Automation, IQ, OQ etc.

Who you are


Bachelor's degree from an engineering discipline and
10 years working experience and understanding of product development, manufacturing, quality control and project management in a pharmaceutical or medical device environment.
5-8 years Quality Assurance/Regulatory Assurance experience from the pharmaceutical, medical devices industry or another regulated field.
Demonstrated validation experience in pharmaceutical or medical device industry.
Familiarity with HVAC system, WFI and automation for environmental monitoring requirements.
Proven experience in ISPE, GAMP5 and GMP requirements.
Hands-on experience with FDA 21 CFR 820, ISO (I9001 & 13485), MDD
Ability to travel and work on site at customer premises to support different project phases based on the planned needs of the project
Ability to multi-task and handle tasks with competing priorities effectively.
Ability to communicate using English while embracing team diversity from worldwide. If positioned in Sweden, fluency in Swedish is desired.

The ideal location for this role is in Uppsala Sweden, however for the right candidate we are open for other placements in Europe.
Our business is growing quickly, and we hire across the board. Interview and selection will happen continuously. Send in you application today!