Quality and Regulatory Support Manager (m/f/d)

Cytiva • Vollzeit • Remote (Schweiz) • vor 12h

Be part of something altogether life-changing!

Working at Cytiva 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

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.
Build and maintain knowledge and understanding of customers' regulatory requirements related to the BioProcess business at a high level.
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 creating and updating guidelines and steering documents.
Participate in change control activities, including writing and releasing formal change control notifications.
Respond efficiently and promptly to customers' regulatory based questions and requests, which will include necessary investigations, preparations and delivery of statements and documentation, use of internal and external databases.

Who you are

Bachelor of Science in Chemistry, Pharmacy or related field, backed up with three or more years' experience in quality, product management or a related field.
Driven with strong ability to work independently, you have a solid understanding of GMP and knowledge of regulatory requirements in the BioProcess industry.
Organized, accurate, target oriented, quality minded and customer oriented with strong written and verbal communication skills.
Flexible and service-minded with the ability to be collaborative and lead cross functional activities across global teams.
Fluent in English and French (written and spoken).

Additional desired Qualifications:

Experience/knowledge of biopharmaceutical process development, quality assurance, and the cell and gene therapy regulatory field.

#Li-onsite

Join our winning team today. Together, we'll 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.

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.

Cytiva

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