GMP/GDP Auditor for CMC Development QA

3 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Role Summary


Lundbeck seeks a highly skilled GMP/GDP Auditor to join its CMC Development QA team. As a key member of this team, you will play a vital role in ensuring the quality and compliance of our CMC vendors.


Key Responsibilities



  • Conduct external audits of CMC vendors to ensure compliance with GMP/GDP regulations
  • Lead internal audits of CMC to identify areas for improvement and ensure adherence to quality standards
  • Collaborate with multiple stakeholders across CMC and vendors worldwide to drive continuous improvement of the audit process
  • Contribute to the development and authoring of SOPs governing audit activities

About the Team


You will report to the Senior Director of CMC Development QA and work closely with QA and CMC Line of Business peers to drive quality and compliance initiatives. The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US, who work together to ensure efficient and compliant quality processes for Small Molecule and Biologics drug candidates, including device activities.


Your Background


To be successful in this role, you will need a master's degree in pharmacy, chemistry, biology, or a similar qualification. You should also have at least 5 years of experience as a GMP/GDP auditor, with a strong background in regulatory compliance. Fluency in English is essential, as you will interact with international stakeholders and vendors. A willingness to travel for on-site audits is also required.


About Lundbeck


Lundbeck is an innovative pharmaceutical company dedicated to bringing treatments for brain diseases to patients worldwide. We offer a dynamic and collaborative work environment, with a strong emphasis on employee well-being and professional development. If you are a motivated and experienced auditor looking for a new challenge, we encourage you to apply for this exciting opportunity.




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