GMP/GDP Auditor, CMC Development QA

Lundbeck

  • København
  • Permanent
  • Fuldtid
  • 6 dage siden
GMP/GDP Auditor, CMC Development QAThis is a great opportunity for an international position as GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will be working as lead auditor and conduct external and internal audits. We offer an exciting job, with the opportunity to audit a broad range of different vendors, supplying Lundbeck´s clinical trials from early stage to late phase for both small molecule and biologic projects.Your new roleYou will join a growing department with an exciting future. As our new colleague, you will support the progression of our pipeline of promising drug candidates by conducting qualification and routine audits.Tasks:
  • Audit of CMC vendors
  • Internal audits
  • Contribute to the continuous improvement of our GMP-procedures.
You will work closely with peers in QA on the vendor management program and audits. You will have a broad collaboration with stakeholders in CMC and externally with vendors all over the world. You will bring on your expertise and knowledge and contribute to our continued improvement of the Vendor Management Program.Your future teamYou will report to the Senior Director of CMC Development QA. The CMC Development QA organization consists of approximately 20 employees based in Copenhagen (DK), Seattle (US) and California (US), who together are responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologics drug candidates. Most of our manufacturing and QC activities are outsourced to CMO´s.We offer a unique position for you to build upon your experiences and professional development.The position is based in Valby, Denmark.What you bring to the team
  • You hold a master’s degree in pharmacy, chemistry, biology, or similar qualification.
  • You are a trained auditor, with at least 5 years of experience as a GMP/GDP auditor.
  • Fluent in English.
  • You are flexible and like to travel, as most of the audits are on site audits.
Our promise to youLundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.We need every brain in the game, and at Lundbeck, we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.Apply nowCan you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.If you have questions, please contact Charlotte Ullits Houlbjerg, Senior Director, CMC Development QA, .Applications must be received by September 22, 2025.We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at .#EveryBrainInTheGameThis job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

Lundbeck