Global GCP Quality Advisor

Novo Nordisk A/S

Søborg

On-site

DKK 743,000 - 1,092,000

Full time

9 days ago

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Job summary

Novo Nordisk A/S invites applications for a GCP Advisor Specialist within Clinical QA in Søborg, Denmark. You will act as a trusted quality partner to the global clinical organisation, providing expert guidance on GCP, quality management systems, and regulatory expectations.

You will drive consistency and continuous improvement across functions and geographies. You will lead cross-functional initiatives, perform vendor assessments, manage CAPA and Change Controls, and support regulatory

Qualifications

A degree in medical, biological, pharmaceutical sciences or another relevant scientific discipline.
Extensive experience within GCP, clinical trial regulations, quality management systems, and clinical development.
Strong understanding of drug development processes, lifecycle management, and regulatory approval requirements.
Experience leading projects and driving cross-functional initiatives in a global organisation.
Excellent communication and stakeholder management skills, with the ability to present complex quality topics clearly and effectively.

Responsibilities

Providing expert GCP advice and quality guidance to stakeholders across global clinical development.
Leading cross-functional improvement initiatives to strengthen quality and compliance.
Perform vendor assessments.
Manage CAPA and Change Controls review and approval, and handle serious breaches.
Train, support and ensure knowledge sharing of quality issues/processes.
Contributing to regulatory inspection readiness and supporting interactions with health authorities globally.