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GMP/GDP Auditor, CMC Development QA Specialist
1 month ago
GMP/GDP Auditor, CMC Development QA Specialist
This is an exciting opportunity to join our team as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. You will have a key role as lead auditor conducting external audits of CMC vendors as well as internal audits of CMC. We offer a challenging job, auditing a broad range of vendors supplying Lundbeck's clinical trials from early stage to late phase including both small molecule and biologic 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 acquisitions of new drug candidates. As our new colleague, you will support the progression of our pipeline of promising drug candidates by conducting initial and routine audits of CMC GMP and GDP vendors.
Tasks:
- External audits of CMC vendors
- Internal audit of CMC
- Contribute to the continuous improvement of the audit process
As auditor, you will collaborate with multiple stakeholders in CMC and vendors all over the world. 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 report to the Senior Director of CMC Development QA and collaborate with peers in QA and CMC Line of Business. You will have a great opportunity to impact current ways of working and improving the audit management 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 Biologics drug candidates including device activities. Most of our manufacturing and QC activities are outsourced to CMOs.
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.
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 like to travel as most of the audits are on-site audits.
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 Senior Director, CMC Development QA – Charlotte Ullits Houlbjerg. 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.
#EveryBrainInTheGame
This job ad is intended for individuals seeking a career opportunity with Lundbeck.
