Senior GMP Compliance Expert

2 weeks ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role


We are seeking a highly experienced Director for Inspection Office to join our team at Novo Nordisk. As a senior expert, you will have a unique opportunity to set direction and provide consultation for line of business in all matters related to interpretations and implementation of cGMP.


Key Responsibilities



  • Manage and host inspections from regulatory authorities
  • Participate in inspection preparations and perform mock inspections
  • Coach personnel involved in inspections and share knowledge through internal teaching
  • Provide compliance guidance to stakeholders to help remediate compliance gaps
  • Represent Novo Nordisk in governmental working groups and conferences

Requirements



  • Extensive experience within quality and GMP at a specialist/leader level
  • GMP inspection experience, including DKMA, EMA, and FDA interaction
  • Knowledge of medical device inspections and ISO 13485 is advantageous
  • Strong ability to work with diverse cross-functional colleagues
  • Excellent interpersonal and stakeholder management skills
  • Fluency in written and spoken English; written and spoken Danish is advantageous

Working at Novo Nordisk


We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work.


Contact


Please refrain from contacting us via email or phone about this position. We will review all applications and reach out to selected candidates.



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