Senior Quality Assurance Auditor, CMC Development
3 weeks ago
GMP/GDP Auditor, CMC Development QA
This is an exciting opportunity for a professional to join our team as a GMP/GDP auditor in CMC Development QA, supporting the development of new innovative treatments for brain diseases. As a lead auditor, you will have an important role in conducting external audits of CMC's vendors as well as internal audits of CMC.
Your new role
You will join a growing department with an exciting future ahead, supporting our current pipeline and expected acquisitions of new drug candidates. As a key member of the team, you will contribute to the progression of our pipeline of promising drug candidates by conducting initial and routine audits of CMC GMP and GDP vendors.
Key responsibilities
- Conduct external audits of CMC vendors
- Conduct internal audits of CMC
- Contribute to the continuous improvement of the audit process
As a GMP/GDP auditor, you will collaborate with multiple stakeholders in CMC and vendors across the globe. 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 improve the audit management 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 Biologics drug candidates, including device activities. Most of our manufacturing and QC activities are outsourced to CMOs.
Requirements
- A master's degree in pharmacy, chemistry, biology, or a similar qualification
- A trained auditor with at least 5 years of experience as a GMP/GDP auditor
- Fluent in English
You will have the opportunity to travel as most audits are on-site audits.
About Lundbeck
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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