Advanced QA Role for Contract Manufacturing Organizations

7 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

About the Job

This role offers the opportunity to work with Contract Manufacturing Organizations (CMOs) located around the world. You will be responsible for ensuring QA oversight by activities such as visits at the CMO, compliance checks, approval of QMS documents, and release of Novo Nordisk insulin products to the market.

You will work with a highly skilled QA team to deliver best-in-class Quality Assurance and ensure the highest quality at our CMOs production.

Main Responsibilities

  • You will handle daily operations such as approval of change requests, deviations, and batch release, as well as supporting in all quality matters.
  • You will build the Quality mindset as well as Quality and Compliance culture at the CMO.
  • You will train the local CMO QA organization to maintain and improve compliant operations.
  • You will engage and energize local employees at the CMOs.

About the Team

The position will be part of the organizational set-up in Global Contract Manufacturing Drug Product - QA Operations – Finished Product Local CMO (LCMO QA). We are responsible for Quality Assurance of Novo Nordisk's local manufacturing CMOs; we currently consist of eight QA colleagues working closely together, covering our operational CMOs in Saudi Arabia, India, Bangladesh, and soon to come South Africa.



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