Clinical Quality Assurance Specialist

6 days ago


Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

Company Overview:

We are a global healthcare leader with a mission to drive excellence in clinical quality process management.

About the Job:

We are seeking a highly skilled and experienced Clinical Quality Assurance Specialist to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.

Key Responsibilities:

  1. Verify and approve Standard Operating Procedures (SOPs) and ensure compliance with external & internal requirements
  2. Support digitalisation of key processes and procedures
  3. Ensure global consistency and compliance in clinical development processes through process documentation, information sharing, and guidance
  4. Be the quality partner for improvement projects
  5. Provide support to stakeholders inside and outside R&D Quality during GCP inspections as applicable
  6. Attend stakeholder meetings and raise/present/discuss relevant quality concerns
  7. Handle and process external clinical requirements impacting the clinical area

Requirements:

  • A degree in nursing, pharmacy, medicine, science or similar
  • A strong command of written and spoken English
  • At least 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations
  • Experience with digitalization of processes to minimize risks through design and focus on quality that matters is preferred
  • Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required
  • Solid experience in verifying and approving SOPs and interpreting GCP, and experience in managing compliance within clinical development
  • In-depth knowledge of Veeva Vault Platform or other clinical management systems is an advantage

What We Offer:

We offer a dynamic and challenging role within clinical process management, where you will have the opportunity to work independently, leveraging your strong GCP knowledge and staying updated with changing regulations.

You will collaborate effectively with cross-functional teams and stakeholders, possessing excellent communication and presentation skills.



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