Chief Risk Officer for Primary Packaging Solutions

1 month ago


Bagsværd, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role

We are seeking a Chief Risk Officer for Primary Packaging to join our Material Manufacturing Development team in Product Supply, Sourcing Operations.

As a key member of our team, you will be responsible for managing risk within medical device development projects from concept to commercialization. This includes reviewing and updating Risk Evaluation and Control Agreements when implementing new or modified Drug Products or combination products.

You will also oversee the process for transfer of the risk package to PrimPack Injectables and govern the process for Life Cycle Management (LCM) of PrimPack product risk documents.

The successful candidate will hold a master's degree or Ph.D. in engineering or another relevant field within the natural sciences and have experience working in GMP environments with risk management tools and methodologies.

Responsibilities

  • Manage risk within medical device development projects
  • Review and update Risk Evaluation and Control Agreements
  • Oversee the process for transfer of the risk package
  • Govern the process for LCM of PrimPack product risk documents

Requirements

  • Master's degree or Ph.D. in engineering or another relevant field within the natural sciences
  • Experience working in GMP environments with risk management tools and methodologies
  • Strong understanding of medical device regulations and standards
  • Proven track record of successfully managing risk within medical device development projects

What We Offer

We offer a competitive salary of approximately €70,000 per year, depending on experience, as well as a comprehensive benefits package including health insurance, retirement plan, and paid time off.



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