Senior QP Delegate, CMC Development QA Specialist
4 weeks ago
Senior QP Delegate, CMC Development QA Role
This is an exciting 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional and personal competencies. We offer a challenging job with a great opportunity to impact our processes and a broad variety in your daily work while ensuring compliance for CMC deliverables from early to late phase pipeline projects. Lundbeck ́s current pipeline includes both small molecule and biologics.
Your new role – why is this a great opportunity?
You will join a growing department with an exciting future ahead, supporting our current pipeline and expected purchases of new drug candidates. As our new colleague, you will support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the IMP for clinical trials. As a Senior QP Delegate, you will have a significant role 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 multiple stakeholders in CMC, regulatory affairs, commercial QA etc. You will contribute to our continued development of the Quality Management System by authoring and approving SOP ́s governing the activities.
Your future team
You will join a new team headed by the Qualified Person. The team has a great opportunity to impact current ways of working and streamlining the QP certification processes. The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who together are responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologic drug candidates including device activities. The majority of our manufacturing and QC activities are outsourced to CMO ́s. You will be working primarily in DK time zone from our office in Valby with app. 1-3 weekly online meetings in the timeslot from 16.00-18.00.
We offer a unique position for you to build upon your experiences and professional development.
What you bring to the team
- 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 to diversity and inclusion
Lundbeck is committed to building a workforce that is as diverse as the people we serve. We believe that every brain in the game matters, and we are dedicated to creating an inclusive environment where everyone can thrive. We welcome applications from candidates of all backgrounds and perspectives.
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate, CMC Development QAThis 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional...
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