Senior Quality Systems Specialist

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Overview

The Clinical Quality Management System (QMS) department at Novo Nordisk A/S plays a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes and procedures. As a Principal GCP Advisor, you will be part of this team and contribute to driving digital quality excellence.

About the Role

In this dynamic and challenging role, you will work closely with our Corporate Vice President for R&D Quality and support colleagues working within the Establish Clinical Evidence process. Your primary responsibility is to ensure regulatory compliance when transforming written standard operating procedures (SOP's) into seamless digital/system-based processes.

You will perform as a quality and process advisor, verifying and approving Standard Operating Procedures (SOPs) and ensuring compliance with external & internal requirements. Additionally, you will be responsible for ensuring global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance.

  1. Supporting digitalisation of key processes and procedures
  2. Verifying and approving SOPs and ensuring compliance with external & internal requirements
  3. Ensuring global consistency and compliance in clinical development processes

As a quality partner, you will provide support to stakeholders inside and outside R&D Quality during GCP inspections and attend stakeholder meetings to raise/present/discuss relevant quality concerns.



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