Quality and Regulatory Support Manager

What you’ll do:

• Support the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change control, and in response to customers' requests for quality, regulatory and technical-related information as it pertains to Bioprocess filtration products.
• Identify and lead cross functional activities, including creating/updating internal and external documentation to align with industry developments and enhanced customer expectations. Function as the regulatory support expert and discussion partner to R&D, QA, Product Management and other functions, and facilitate risk-based decisions.
• Prepare, update and review regulatory support documentation, including Validation Guides, statements, certificates and other regulatory related documentation for new and existing products.
• Participate in change control activities and risk assessments, writing change notifications, developing notification qualification packages, and releasing to customers. 
• Respond efficiently and promptly to customers' regulatory based questions and requests, which will include investigations, preparations and delivery of statements and documentation, use of internal and external databases.

Who you are:

• Bachelor of Science degree in Biochemistry/Chemistry or related field
• Five or more years of experience in GMP, quality, product management or a related field
• Understanding of quality and regulatory requirements in the Bioprocess industry
• Driven with experience leading cross-functional activities across global teams
• Strong written and verbal communication skills, fluent in English

It would be a plus if you also possess previous experience/knowledge of:

• Biopharmaceutical/Bioprocess filtration products and techniques

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.