Senior QP Delegate, CMC Development QA Transformation
7 days ago
Lundbeck is a global biopharmaceutical company that specializes in the development and manufacturing of innovative treatments for brain diseases. Our mission is to make a meaningful difference in the lives of patients by developing and delivering novel therapies that address unmet medical needs.
Job SummaryWe are seeking a Senior QP Delegate to join our CMC Development QA team. As a Senior QP Delegate, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Product (IMP) supplies for clinical trials. This is an exciting opportunity to contribute to the development of new innovative treatments for brain diseases and work with a talented team of professionals who share your passion for quality and innovation.
About the RoleThe successful candidate will have a Master's degree in pharmacy or a similar qualification, with at least 5-10 years of experience in a GMP regulated area. You will have experience in biologic drug substance manufacturing and previous experience as a QP delegate would be an asset. You will be responsible for ensuring patient safety and GMP compliance of the IMP for clinical trials, as well as driving the continuous improvement of the QP Delegate processes.
Responsibilities- QP confirmation of Biologic Bulk Drug Substance and Drug Product
- QP certification of IMP
- QA assessment of deviations, change controls and laboratory deviations
- Approval of master batch records
- Handling of complaints
We offer a unique position for you to build upon your experiences and professional development. The job offers great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role. You will join a growing department with an exciting future ahead, supporting our current pipeline and expected purchases of new drug candidates. Our culture is characterized as collaborative - a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them.
BenefitsWe offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being. The salary for this position is estimated to be around $120,000-$150,000 per year, depending on experience. If you have questions or want to hear more, please feel free to contact Director, CMC Development QA – Malene Brandt-Larsen.
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