Lead Auditor, Pharmacovigilance

We are searching for a full time Pharmacovigilance auditor, responsible for performing PV audits internally at the ALK Headquarters and ALK Affiliates, as well as audits of external collaborators, service providers, and distributors. Around 5 travelling days a month is expected. As Lead Auditor, you will become part of the Global Quality function located in ALK Headquarters in Hørsholm, Denmark, as a member of a committed, enthusiastic, and experienced team working with many different QA tasks, processes, and systems within different GxP areas. Your primary responsibility areas and tasks will be:

1. Performing PV audits as Lead auditor, on your own, and in collaboration with other PV and GDP Lead auditors in ALK.
2. Planning, execution, reporting, and CAPA follow up.
3. Supplier Management, qualification of external collaborators, service providers, and distributors.

We expect that you have the following qualifications:

1. Experience as Lead Auditor within PV performing internal audits and audits of external collaborators (distributors and service providers) and ability to start directly in a PV Lead Auditor position.
2. B.Sc. / M.Sc. in Health Science with 5+ years of experience within pharmacovigilance regulated areas, including experience with quality management systems and tools.
3. Experience with audits within other GxP areas is an advantage.
4. Strong drive, takes own initiatives and proactive action.
5. Ability to work independently, but also a strong team player.
6. Relation builder, working respectfully across different cultures with flexibility.
7. Strong cross-cultural communication skills verbally as well as written.
8. Excellent in verbal and written communication in Danish & English.

We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised 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 organisation, 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.