Global GCP Quality Advisor | Clinical QA Leader

Novo Nordisk A/S

Søborg

On-site

DKK 743,000 - 1,092,000

Full time

6 days ago
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Job summary

Novo Nordisk A/S in Søborg, Capital Region of Denmark, is hiring a GCP Advisor Specialist to partner with the global clinical organization on Good Clinical Practice, quality management systems, and regulatory expectations. You will drive consistency, compliance and continuous improvement while shaping a culture of simplicity and innovation.

You will influence processes across functions and geographies, support regulatory interactions, and help ensure inspection readiness within Clinical QA.

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, 10+ years of experience.
  • 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 and participating in cross-functional improvement initiatives and projects to strengthen quality and compliance.
  • Manage critical quality processes, including 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.

Skills

GCP expertise
Quality mindset
Stakeholder management
Project leadership

Education

Science degree (medical/biological/pharmaceutical)

Job description

Novo Nordisk A/S in Søborg, Capital Region of Denmark, is hiring a GCP Advisor Specialist to partner with the global clinical organization on Good Clinical Practice, quality management systems, and regulatory expectations. You will drive consistency, compliance and continuous improvement while shaping a culture of simplicity and innovation.

You will influence processes across functions and geographies, support regulatory interactions, and help ensure inspection readiness within Clinical QA.

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