QA Change Control Specialist

Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
What You'll Do
As the QA Change Control Specialist, you will manage changes on launched products ensuring compliance to Cytiva Quality Management System.
You will review and approve risk assessments, review and approve low risk changes as well as review and prepare medium and high-risk changes for approval by our Change Control Board (CCB). You will work close with change leaders from different parts of the organization, the cross-functional team of change control certified QAs and the Change Control Leader.
You will also, as part of the Site QA Team, support key quality activities and be open to take on additional tasks supporting the overall performance of the team
As the QA Change Control specialist, you are knowledgeable in the Change Control Process and how to use supporting systems (Veeva, Magic). You are also a great business partner supporting with general Quality Assurance knowledge.
Who you are
You have relevant university education, experience in working with quality assurance, ISO9001/13485/cGMP, experience of working with Risk Assessments (FMEA), Change Management, and you can communicate effectively (both written and oral) in Swedish and English.
You can work independently in a changing environment. You have the ability to influence positive change and you energize and motivate others by involvement and trust.
You are quality focused, attentive to detail and pragmatic without compromising compliance. You understand the importance of clear communication.
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Our business is growing quickly and we hire across the board. Interview and selection will happen continuously and an opening can be filled before last day of application, which is February 4th.
For questions about the role, please contact hiring manager Christine Wahlgren, christine.wahlgren@cytiva.com, +46 70 620 57 01.
Want to know more? Take a look at our Careers website, Instagram and LinkedIn page!
Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
As part of the Danaher family of companies, our work at Cytiva is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, our relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.