GCP Advisor Specialist

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Søborg

Clinical Compliance and Inspections, R&D

Søborg (Copenhagen), Onsite

Are you passionate about clinical research and ensuring compliance with global standards? Do you apply a risk‑based approach to quality? And do you thrive in a dynamic environment where you can lead inspections and drive quality improvements? If so, we have an exciting opportunity for you to join [xxxxx] as a GCP Advisor Specialist.

Read on and apply today!

Your new role

This position is designed for an expert specialist who operates with confidence and independence, brings deep subject matter expertise, and navigates complex, high‑impact tasks across the area. You will be recognised as a trusted expert within one or more key processes, applying best practices while shaping decisions that matter for the business. With a strong cross‑functional understanding you will act as a go‑to resource for colleagues, providing guidance, direction, and knowledge in areas critical to [xxxxx]’s success.

Your main accountabilities will be:

  • Provide expert GCP advice and support to the organisation.



  • Drive global consistency and compliance in clinical development processes worldwide.



  • Lead sponsor inspections and support site inspections with health authorities globally.



  • Ensure coordination of all GCP inspections and drive the global inspection readiness process.



  • Act as a quality partner to R&D, enabling quality by design and deploying compliance data insights.



  • Represent Clinical Quality in cross-functional initiatives and improvement projects.



  • Promote a proactive focus on process improvement, simplicity, agility, and innovation



Your new department

Clinical Compliance and Inspections plays a critical role in safeguarding the quality, integrity, and regulatory compliance of clinical trial activities. The department acts as a trusted partner to Clinical Development and R&D, ensuring that studies are conducted in accordance with global regulatory requirements, GCP standards, and internal quality frameworks. With a strong focus on inspection readiness, risk‑based quality, and continuous improvement, the team supports successful health authority inspections and promotes a proactive quality mindset across the organization. Through expert guidance, oversight, and collaboration, Clinical Compliance and Inspections helps ensure that patient safety, data integrity, and regulatory excellence remain at the heart of [xxxxx]’s clinical activities.

Your skills & qualifications

We are searching for a professional with positive and pragmatic approach to problem-solving and a strong desire to create, optimise, and simplify processes.

To thrive and succeed in the role, we expect you to have:

Need to have:

  • A degree in medical, biological, or pharmaceutical sciences (or similar).



  • At least 7 years of experience in clinical research and drug development.



  • Detailed knowledge of GCP and global regulatory requirements.



  • Experience with global collaboration and project-oriented organisations.



  • Strong communication skills and fluency in English (written and verbal).



  • Sound IT skills, including proficiency in Microsoft Office.



Nice to have:

  • Experience with medical devices.



  • Experience with phase I trials



  • Experience with digitalisation of quality projects.



Moreover, you bring a strong strategic mindset with a clear focus on process optimisation, combined with the ability to influence, set direction, and apply a risk‑based approach to quality. You approach challenges with a positive and pragmatic problem‑solving attitude and are proactive, courageous, and equipped with excellent communication and interpersonal skills. Highly organised and detail‑oriented, you never lose sight of the bigger picture, remaining quality‑conscious and naturally curious. While you thrive as a collaborative team player, you are equally comfortable working independently and enjoy partnering across departments in an international environment.

Working at [xxxxx]

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. The video below features colleagues worldwide speaking about why they’re proud to work at [xxxxx] and highlights the culture, collaboration and long-term impact. Together, for the long-term!

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Contact

For more information on this role, please contact Malene Wibe Alexander at [xxxxx] or +[xxxxx].

Deadline

Apply before 27 April 2026.

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

At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 13.4.2026, men kan have været deaktiveret og genaktiveret igen.

  • Øvrige
  • Søborg

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