Global Contract Manufacturing Expert

3 days ago


Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

Join our team as a Global Contract Manufacturing Expert and take on the challenge of ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).

About the Role

You will be responsible for overseeing the quality processes of our CMOs for Active Pharmaceutical Ingredients (API) and Drug Substance (DS). This involves working closely with internal and external business partners and managing a high level of complexity in daily tasks.

The role requires:

  • Ensuring that our products are manufactured according to cGMP and our Marketing Authorizations.
  • Numerous encounters daily with both internal and external business partners and a high level of complexity in your daily tasks.
  • Handling of documentation from the contract manufacturers is a part of the job and you are also expected to participate in audits performed at the CMO and ensure sufficient follow up on CAPAs.
  • QA support and GMP guidance to our partners and final release of the products from CMOs to the further process in Novo Nordisk.
  • Expected travel is around 10-15 days a year as the CMOs are located outside Denmark primarily Europe and US.

In addition to your technical skills, you will also be part of a dynamic and supportive team that values good social relations and prioritizes making room for fun at work.

Responsibilities

  • Ensure the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).
  • Oversee the quality processes of our CMOs for Active Pharmaceutical Ingredients (API) and Drug Substance (DS).
  • Work closely with internal and external business partners and manage a high level of complexity in daily tasks.

Requirements

  • Hold an academic degree as Pharmacist, Engineer or similar.
  • Possess a minimum of three years of experience in the pharmaceutical industry, preferably in production or QA.
  • Have gained a solid and up-to-date knowledge of quality and GMP requirements.
  • Have great communication and collaboration skills and speaks and writes English fluently.


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