Global GCP Quality Advisor & Compliance Leader

Cari

Søborg

Remote

DKK 743,000 - 1,092,000

Full time

8 days ago
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Job summary

Novo Nordisk in Søborg, Denmark, is seeking a GCP Advisor Specialist in Clinical QA to partner with the global clinical organization on Good Clinical Practice, quality management systems, and regulatory expectations.

You will drive consistency, lead cross-functional improvement projects, perform vendor assessments, manage CAPA and Change Controls, and support regulatory inspections. Join a team delivering quality excellence across the development lifecycle.

Qualifications

  • Degree in medical, biological, pharmaceutical sciences or related field.
  • 10+ years of experience in GCP, clinical trials, quality systems and development.
  • Strong knowledge of drug development processes and regulatory requirements.
  • Experience leading projects and driving cross-functional initiatives in a global organisation.
  • Excellent communication and stakeholder management skills.

Responsibilities

  • Provide expert GCP advice and quality guidance to stakeholders across global clinical development.
  • Lead cross-functional improvement initiatives to strengthen quality and compliance.
  • Perform vendor assessments.
  • Manage CAPA and Change Controls review/approval and handle serious breaches.
  • Train and share knowledge on quality issues/processes.
  • Contribute to regulatory inspection readiness and interactions with health authorities globally.

Skills

GCP expertise
Quality mindset
Stakeholder management
Project leadership
Regulatory compliance

Education

Medical/biological/pharmaceutical sciences degree

Job description

Novo Nordisk in Søborg, Denmark, is seeking a GCP Advisor Specialist in Clinical QA to partner with the global clinical organization on Good Clinical Practice, quality management systems, and regulatory expectations.

You will drive consistency, lead cross-functional improvement projects, perform vendor assessments, manage CAPA and Change Controls, and support regulatory inspections. Join a team delivering quality excellence across the development lifecycle.

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