Pharmacovigilance audits, QA Business Partner – Global Quality

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

We are looking for a Pharmacovigilance 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 and many different quality tasks, processes and systems across multiple GxP areas. You will be responsible for performing remote and onsite PV audits of ALK affiliates, external collaborators, service providers and distributors. Approximately 20 travelling days a year is expected.

Your primary responsibility areas and tasks will be:

• Planning, performing, and reporting of GVP audits.
• Audit CAPA follow up.
• Risk management and tools.
• Supplier management.
• Document Management.
• Conduct stakeholder meetings.

Your profile
We expect that you have the following qualifications:

• Extensive experience within pharmacovigilance regulated areas, demonstrating a strong understanding of quality management systems and tools, even if you have not served formally as an auditor.
• Experience with audits as Auditor or participation in audits and inspections, is an advantage.
• B.Sc. / M.Sc. in Health Science with 5+ years of experience within pharmacovigilance 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.

If you do not have prior experience as an auditor, training will be provided to equip you with the necessary skills.

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 looking for both personal and professional development. ALK is a global pharmaceutical company specialized in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded 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.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 31 December 2025.

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

We are looking forward to hearing from you!