GCP Advisor Specialist, Clinical QA, Søborg, Denmark (Denmark, Søborg)

Novo Nordisk A/S

Søborg

On-site

DKK 743,000 - 1,092,000

Full time

4 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.

Skills

GCP expertise
Quality mindset
Stakeholder management
Communication skills
Project leadership

Education

Degree in medical/biological/pharmaceutical sciences

Job description

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Quality

Are you passionate about quality, compliance, and driving excellence in clinical development? Do you thrive in a global environment where you can influence processes, advise senior stakeholders, and help shape the future of quality across clinical research? Join Novo Nordisk as a GCP Advisor Specialist and play a pivotal role in ensuring compliance, continuous improvement, and quality oversight across our worldwide clinical development activities.

Your New Role
As a GCP Advisor Specialist within Clinical QA, you will act as a trusted quality partner to the global clinical organisation, providing expert guidance on Good Clinical Practice (GCP), quality management systems, and regulatory expectations. You will work across functions and geographies to drive consistency, compliance, and continuous improvement, while contributing to a culture of simplicity, agility, and innovation.

Key responsibilities include:

  • 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.

In this role, you will have significant influence on processes, decision-making, and quality culture across the organisation.

Your New Department
You will join Clinical QA, a highly skilled and collaborative department within R&D Quality. Our mission is to serve as a quality anchor for clinical research worldwide by ensuring compliance with regulatory requirements and driving quality excellence throughout the clinical development lifecycle.

The department partners closely with Development, Research & Early Development, Global Regulatory Affairs, Global Safety, Clinical Drug Development, Clinical Vendor Management & Compliance, and other key functions across Novo Nordisk. Together, we work to continuously strengthen quality systems, optimise processes, and enable the successful development of innovative treatments for patients around the world.

As part of a global organisation, you will work with colleagues from diverse cultural and professional backgrounds, creating opportunities to expand your expertise and build a broad professional network.

Your Skills and Qualifications
To succeed in this position, we expect you to bring a strong quality mindset, extensive GCP expertise, and the ability to navigate complex stakeholder environments.

We are looking for a candidate who has:

  • 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.

As a person, you are proactive, collaborative, and adaptable. You demonstrate sound judgement, a risk-based approach to quality, and the ability to influence stakeholders across functions and organisational levels. You enjoy improving ways of working and are motivated by the opportunity to make a meaningful impact on quality and compliance globally.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer
At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage.

Salary: For this role, the Annual Base Salary ranges from 742,600.00 to 1,091,600.00 DKK, corresponding to the level of the position.

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.

Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks.

Learn more about our Reward Philosophy here.

Contact:
For further information, please contact Najat EL Bariaki, Director at +45 30791291

Deadline:
Please submit your application no later than 25 September 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we’re creating lasting change for long-term health. For over 100 years, we’ve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what’s possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we’re making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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