Senior QP Delegate, CMC Development QA Expert
2 weeks ago
Job Title: Senior QP Delegate, CMC Development QA
This is a unique opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials.
Your Role - Why is this a Great Opportunity?
You will join a growing department with an exciting future ahead, supporting our current pipeline and anticipated purchases of new drug candidates. As our new colleague, you will ensure patient safety and GMP compliance of the IMP for clinical trials, while driving the continuous improvement of the QP Delegate processes.
Key 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
As our new Senior QP Delegate, you will collaborate with various stakeholders in CMC, regulatory affairs, commercial QA, and other departments. You will contribute to our continued development of the Quality Management System by authoring and approving SOPs governing the activities.
Your Future Team
You will join a new team headed by the Qualified Person, where you will have the opportunity to impact current ways of working and streamline the QP certification processes. 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 to support the development of Small Molecule and Biologic drug candidates, including device activities.
We offer a unique position for you to build upon your experiences and professional development, with great opportunities to grow your competencies and knowledge and to widen your duties and responsibilities as you develop in the role.
Requirements:
- You hold a master's degree in pharmacy or similar qualifications to meet the requirements of a QP Delegate
- Experience in biologic drug substance manufacturing
- At least 5-10 years of experience in a GMP regulated area, either in Manufacturing, Quality Control, or Quality Assurance
- Previous experience as a QP delegate would be an asset
- You are fluent in English
Lundbeck's Commitment:
Lundbeck offers an inspiring workplace, passionate colleagues, and a culture 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. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
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