CMC QA Integration Specialist

1 day ago

Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

Are you looking for an exciting role where you can bring your QA skills into play in the quality integration of acquired assets into Novo Nordisk? Do you want to set new standards and processes for successful quality integration? Do you get energy out of working in a dynamic and very skilled team with various assignments and challenges?

If so, you might be our new CMC QA Integration Specialist, apply now

The position
As a CMC QA Integration Specialist, you will:

  • Act as Sub Stream Lead for the integration of acquired CMC QA functions (people, processes, and procedures) in the quality workstream across Novo Nordisk
  • Provide CMC QA advice and directions to the integration strategies and transition activities during due diligence and merger & acquisitions
  • Set new standards and processes for quality integration of corporate assets into the Novo Nordisk pipeline
  • Bring your CMC and QA skills into play by solving complex quality issues, mitigating quality risks, and ensuring patient safety in the transition of acquired assets into Novo Nordisk
  • Support the integration projects in the quality assessment of the full supply chain to identify quality gaps, opportunities, and risks

Qualifications

To succeed in this role, you:

  • Hold a master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or similar
  • Have extensive experience in CMC, QA, or production-related roles
  • Have gained said experience within the pharmaceutical industry
  • Have in-depth knowledge of the pharmaceutical product value stream and expertise in GxP regulations and guidelines (EU and US)
  • Are fluent in English, both written and spoken

On a personal level, you have a structured way of working, are solution-oriented, and have a can-do attitude. You have an outgoing and self-driven personality, take the initiative, are agile, and embrace new ways of working.

Finally, your excellent communication skills allow you to engage at all levels of the organization, act proactively, and make independent decisions.

About the department

PDQ Integration is a new team in Due Diligence & Integration Quality responsible for the quality integration of acquired corporate assets from due diligence and final deal, driving the transition, initial integration, and handover to the Product Development QA Project organization.

You will become an important player in our new dynamic team of competent people with a long history within CMC and quality assurance of IMP. The department is characterized by a high level of professionalism, flexibility, and collaboration.

We have a great and informal working environment where we enjoy sharing and learning from each other and also focus on good social relationships and having fun at work. The team is based in Høje Tåstrup, Denmark.

Working at Novo Nordisk

At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop; we seize them. From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.

Contact

For further information please contact Jane Lykke Saxbøl, , Phone +45 30758619 or get to know us better by visiting

Deadline

5 January 2025

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we're life-changing.

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