Danaher Corporation Regulatory Compliance Leader, Qualification Services in Marlborough, Massachusetts
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.
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 expert and discussion partner to R&D, QA, Product Management and other functions and regions
Participate in project teams as QS regulatory expert
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
Create and maintain a database of common customer review questions, responses and to justify 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 other related field
Ten or more years of experience in quality/regulatory or a related field
Understanding of GMP and knowledge of regulatory requirements in the BioProcess industry
Organized, accurate, target oriented, quality minded and customer oriented
Strong written and verbal communication skills
Flexible and service-minded with the ability to be collaborative
Strong ability to work independently, drive
Greater than ten years’ experience with biopharmaceutical process development and quality assurance
Expertise in the regulatory/QA of equipment/process qualification
Desired: Experience in Cytiva product development or production and deep knowledge of Cytiva products and QS approach to documentation.
Experience leading cross-functional activities
Strong computer skills with prior experience in systems, including Microsoft Office products, Magic, Oracle and Lotus Notes
Based either in Sweden, UK and US (remote/office)
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.