CMC QA Integration Specialist

4 weeks ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time
Job Title: CMC QA Integration Specialist

We are seeking an experienced Clinical Manufacturing and Control (CMC) Quality Assurance (QA) professional to join our team as a CMC QA Integration Specialist. This is an exciting opportunity for someone who wants to bring their expertise in quality assurance, regulatory compliance, and pharmaceutical manufacturing to our company.

About the Role:

  • This position will be responsible for providing expert advice on CMC QA strategies and ensuring compliance with regulations such as GxP.
  • The successful candidate will lead the integration of acquired assets into Novo Nordisk's quality workstream, setting new standards and processes for quality integration.
  • You will collaborate with cross-functional teams to identify and mitigate quality risks, ensuring patient safety and product quality.
  • As a CMC QA specialist, you will have the opportunity to develop and implement new procedures, improve existing ones, and provide training to colleagues.
  • You will also contribute to the development of business cases and proposals to support strategic decisions.

About You:

  • A Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or a related field.
  • At least 5 years of experience in CMC QA, production, or a related field within the pharmaceutical industry.
  • In-depth knowledge of pharmaceutical product value streams, GxP regulations, and EU/US guidelines.
  • Excellent communication and problem-solving skills, with the ability to work independently and collaboratively in a dynamic environment.
  • Familiarity with data-driven decision-making and analytical tools.

What We Offer:

  • An estimated salary range of $120,000-$180,000 per annum, depending on your experience.
  • A competitive benefits package, including health insurance, retirement savings plan, and paid time off.
  • A collaborative and dynamic work environment with opportunities for growth and development.
  • The chance to work with a global leader in diabetes care and biopharmaceuticals.

How to Apply:

If you are passionate about delivering high-quality products and services, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter explaining why you are the ideal candidate for this role.



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