Regulatory Compliance Leader, Qualification Services
Cytiva Sweden AB / Kemiingenjörsjobb / Uppsala
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hela Sverige 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.
For our Qualification Services (QS), we are looking for a Regulatory Compliance Leader to advise our team, spread out across the world, on our customers regulatory and quality requirements. Have you worked within a GMP regulated production environment in life science? Are you ready to take the next step to apply your expertise within validation and qualification of equipment together with your knowledge of QMS systems? Apply for this position today!
What you'll do
Build and maintain knowledge and understanding of customers' regulatory requirements related to the QS business at a high level
Develop and update the qualification documentation approach to align with current regulatory guidelines and to better assist customers through an audit by a regulatory authority.
Participate in creating and updating guidelines and requirements for NPIs to ensure a consist approach across all QS products
Act as QS regulatory specialist and discussion partner to R&D, QA, Product Management and other functions and regions
Lead cross-functional activities when required
Ensure QS (and wider service team) is kept well-informed of current regulatory updates and any hot topics of concern for our customers
Identify a regulatory training plan for QS team members aligned to R&R of associate
Build, and keep updated, a database of common customer review questions and responses. Also to explain and defend the testing performed and the testing not performed during any phase of C&Q.
Who you are
Bachelor of Science degree in engineering, biotech, or related field
At least ten years' experience in a GMP production environment within the life science industry
A deep expertise of quality assurance and regulatory requirements for equipment and process validation and/or qualification
Experienced in leading QMS activities, such as CAPA:s and other product & process related improvement processes.
Organized, accurate, target oriented, quality minded and customer oriented
Flexible and service-minded with the ability to be collaborative, leading cross-functional activities, at the same time being a hands-on person
Experienced user of Microsoft Office products, Magic, Oracle and Lotus Notes
Proficiency in English, both in written and verbal communication
This position can be based either in Sweden, UK and US (remote/office).
Applications will be handled continuously. We look forward to your application today.
When you join us, you'll also be joining Danaher's global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we'll empower you to push the boundaries of what's possible.
If you've ever wondered what's within you, there's no better time to find out.
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.
Publiceringsdatum2021-06-28Så ansöker duSista dag att ansöka är 2021-07-28
Klicka på denna länk för att göra din ansökanAdressCytiva Sweden AB
Björkgatan 30
75184 Uppsala
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Cytiva Sweden AB (org.nr 556108-1919)
Björkgatan 30 (
visa karta)
751 84 UPPSALA
Arbetsplats Cytiva Sverige AB
Jobbnummer 5832623
Observera att sista ansökningsdag har passerat.