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Qualification Services Regulatory Program Manager

Cytiva Marlborough, Massachusetts, United States of America Category Project/Program Management Job Id R1285944 Location Marlborough, Massachusetts, United States of America
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JOB DESCRIPTION

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

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. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The Qualification Services Regulatory Program Manager for Cytiva is responsible for overseeing Qualification Services strategic initiatives with responsibility to ensure customer regulatory needs are met in the delivered product.

This position is part of Global Qualifications Services located in Uppsala, Sweden or Marlborough, Massachusetts and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Collaborate with product management to identify product gaps vs customer regulatory requirements, develop business cases for new and updated Qualification Services product offerings and ensure available product offerings match customer regulatory requirements
  • Define standard regulatory requirements of Qualification Services products and collaborate with cross-functional teams to implement requirements in new and existing products
  • Act as Qualification Services regulatory expert and discussion partner to cross-functional teams, representing voice of customer regulatory needs to facilitate risk-based product related decisions
  • Support the Business and Customers in a global environment by providing regulatory expertise 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 Qualification Services products.
  • Stay up-to-date with, interpret, document and implement new and evolving regulatory requirements as they apply to the countries and regions of interest

Who you are:

  • Bachelor of Science degree in Engineering, Biochemistry/Chemistry or biopharmaceuticals related field
  • Ten or more years of experience in GMP, quality, product management or a related field
  • Understanding of GMP and regulatory requirements in the Bioprocess industry, including but not limited to 21 CFR Part 11 and EU GMP Annex 11
  • Strong written and verbal communication skills, fluent in English
  • Driven with experience leading cross-functional activities across global teams

It would be a plus if you also possess previous experience in:

  • Biopharmaceutical/Bioprocess filtration products and techniques

#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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

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