Principal Quality Assurance Manager for Clinical Trials

15 hours ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time
About the Role

We are seeking a highly experienced and motivated Principal Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S.

The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced Active Pharmaceutical Ingredients (API) for usage in clinical trials. Key responsibilities include ensuring best-in-class quality assurance of API, challenging and approving documents related to development, manufacture, stability, and status assignment, and participating in regulatory inspections and audits.

In this role, you will be part of the Product & Cell Bank team consisting of both QP delegates, QA professionals, and QA assistants. Our team's culture ensures a healthy and fun working environment where we value strong relationships, people growth, and optimization of processes.

We strive for simplicity every single day, ensuring Novo Nordisk's critical delivery of medicine to patients. As part of Novo Nordisk Quality, you will support the business in delivering safe and high-quality products, manufactured in compliance with legislation.

Key Responsibilities
  • Ensure best-in-class quality assurance of API for clinical trials
  • Challenge and approve documents related to development, manufacture, stability, and status assignment
  • Participate in regulatory inspections and audits
Requirements
  • Hold a Master in Pharmacy, Engineering, Biology, Chemistry or similar to fulfill the requirements to become a


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