Senior QP Delegate, CMC Development QA Specialist
3 weeks ago
Senior QP Delegate, CMC Development QA Specialist
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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional and personal competencies. We offer an exciting 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.
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
Our promise to you
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.
Apply now
Can 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 or want to hear more, please feel free to contact Director, CMC Development QA – Malene Brandt-Larsen, phone +45 31 70 59 53. Applications must be received by October 31th 2024. Relevant candidates will be invited for interviews as applications are received.
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 .
#EveryBrainInTheGame
This 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.
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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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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate, CMC Development QAThis is a great opportunity to contribute to the development of new innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. You will leverage your professional and personal competencies to drive the continuous improvement of the...
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