GLP QA ProfessionalQA Compliance Manager – Global Quality

Are you ready to take the next step in your QA careerWould you like to join Global Quality with focus on ensuring the Quality System is fit for purpose for non-clinical activities/GLP supporting ALKs Research and Drug Discovery area and auditing within the GLP area Are you driven by working closely with stakeholders fulfilling regulatory requirements with focus on simplicity solutions and collaboration Do you have a strong quality mindset

We are looking for a QA Compliance Manager for a new position in Global Quality. You will be based at the ALK headquarters in Hørsholm Denmark close to our stakeholders in Global Research & Drug Discovery (GRⅅ).

The position
In Global Quality you will be a member of a committed enthusiastic and experienced team working as a QA Business Partner for R&D and Commercial Operations with many different quality tasks processes and systems across multiple GxP areas.

You will be responsible for ensuring the quality processes cover and include the GLP specific requirements as well as supporting GRⅅ with their processes to meet the requirements. Audits will also be your responsibility area covering both internal and external audits of CROs and suppliers. Approximately 15 travelling days a year is expected.

Your primary responsibility areas and tasks will be:

• QA Business Partner to GRⅅ area supporting non-clinical and GLP activities.
• Ensuring ALK Quality Management System captures GLP specific requirements.
• Document Management and record management.
• QA review and approval of SOPs GLP protocols reports etc.
• Supplier Management activities related to CROs and suppliers.
• Planning performing and reporting of audits including CAPA follow up.
• Risk management and tools.

Your profile
We expect that you have the following qualifications:

• Extensive experience within regulated GLP areas demonstrating a strong understanding of quality management systems.
• Experience within the GCP regulated area is an advantage.
• Experience with audits as Lead Auditor or participation in audits and inspections is an advantage.
• . / . in Health Science with 10 years of experience within GLP regulated areas. including experience with quality management systems and tools.
• 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 communicator with verbal and written English communication skills.

Become a part of ALK
We offer an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specializing in allergy immunotherapy. We are driven by a high level of professionalism integrity an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be part of an engaged and informal team who values skill and knowledge creation. 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.

Do you want to learn more about our company we encourage you to visit us .

Apply
Apply by attaching your CV and a short letter of motivation no later than 22 January 2026.

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

For further information regarding the position please contact Vice President Global Quality Siren Jenssen Østerberg on. We kindly ask you not to contact us with commercial inquiries.

We are looking forward to hearing from you!