Danaher Corporation Regulatory Compliance Leader, Qualification Services in York, United Kingdom
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.
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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.If you’ve ever wondered what’s within you, there’s no better time to find out.