GCP Lead Auditor - Global Quality

Are you ready to take the next step in your Quality career? Would you like to join Global Quality with focus on audits and GCP? Are you driven by working globally? Do you have a strong quality mindset?

We are looking for a GCP specialist for this exiting position. You will be based at the ALK headquarters in Hørsholm, Denmark and have the world as your workplace.

The position

In Global Quality, you will be a member of a committed enthusiastic and experienced team working as a QA Business Partner with audits, supplier management, processes, systems and many other quality tasks across multiple GxP areas. In this role, you will also collaborate closely within a group of QA Business partners, functioning as key collaborators to the Global Clinical Development area, ensuring a collaborative and solution-oriented approach.

You will be responsible for performing remote and onsite GCP audits of Investigator sites, CRO's and Suppliers. Approximately 20 travelling days a year is expected.

Your primary responsibility areas and tasks will be:

• Planning, performing, and reporting of GCP audits.
• CAPA follow up after audits.
• Document Management and tools.
• Supplier management and tools.
• Risk management and tools.

Your profile

We expect that you have the following qualifications:

• Experience as Lead Auditor
• B.Sc. / M.Sc. in Health Science with 10+ years of experience within GCP regulated areas.
• Extensive experience within GCP regulated areas, demonstrating a strong understanding of quality management systems and tools.
• Experience with GCP related IT systems is an advantage.
• A strong quality mindset, with a consistent commitment to maintaining a high standard in all quality-related processes.

Personal characteristics:

• Has high drive, takes own initiatives and proactive action.
• Ability to work independently, but also a strong team player.
• Relation-builder working respectfully across different cultures with flexibility.
• Excellent cross-cultural communicator with verbal and written Danish & English communication skills.

Become a part of ALK

We offer an attractive working environment for individuals  seeking  both personal and professional development. ALK is a global pharmaceutical company specialized in allergy immunotherapy, driven by professionalism, integrity and an openminded approach. You will be part of an engaged and informal team where core values include skill sharing, knowledge creation, and building strong partnerships.

The result of your efforts will be significant throughout the organization, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply

Apply by attaching your CV and a short letter of motivation, no later than 23 February 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Vice President Global Quality, Siren Jenssen Østerberg on +45 5089 9540.

We are looking forward to hearing from you!