Digital Process Transformation Lead in Clinical Quality

5 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Novo Nordisk A/S is a dynamic company in an even more dynamic industry. We are seeking a highly skilled Principal GCP Advisor to join our Clinical Quality Management System (QMS) department.

About the Team

As a key member of the team, you will be responsible for ensuring regulatory compliance when transforming written standard operating procedures (SOPs) into seamless digital / system-based processes. You will also provide quality and process guidance to our Corporate Vice President for R&D Quality and support colleagues working within the Establish Clinical Evidence process.

Our team is committed to delivering high-quality drug development processes that meet regulatory requirements. We strive for excellence without fixating on perfection and embrace the spirit of experimentation. The ideal candidate will have a strong command of written and spoken English, a master degree in nursing, pharmacy, medicine, science or similar, and at least 12 years of experience in clinical research and drug development.

  • Key Responsibilities:
  • Supporting the digitalisation of key processes and procedures
  • Verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements
  • Ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
  • Being the quality partner for improvement projects
  • Providing support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
  • Attending stakeholder meetings and raise/present/discuss relevant quality concerns
  • Handling and processing external clinical requirements impacting the clinical area
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