Global GCP QA Advisor - Clinical Quality & Compliance

Novo Nordisk; Gladsaxe Kommune; On-site; DKK 743,000 - 1,092,000; Full time

Job summary

Novo Nordisk is seeking a GCP Advisor Specialist within Clinical QA to partner with the global clinical organization, providing expert guidance on Good Clinical Practice, quality systems, and regulatory expectations.

You will drive consistency, compliance, and continuous improvement across geographies, influence senior stakeholders, and help shape the quality culture and processes that support the development of innovative therapies for patients worldwide.

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, ideally with 10+ years of relevant 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.
• Perform vendor assessments.
• 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

Stakeholder management

Project leadership

Quality mindset

Education

Degree in medical/biological/pharmaceutical sciences

Job description

Novo Nordisk is seeking a GCP Advisor Specialist within Clinical QA to partner with the global clinical organization, providing expert guidance on Good Clinical Practice, quality systems, and regulatory expectations.

You will drive consistency, compliance, and continuous improvement across geographies, influence senior stakeholders, and help shape the quality culture and processes that support the development of innovative therapies for patients worldwide.