Quality Assurance Specialist for CMC Development
2 weeks ago
Senior Vendor Specialist, CMC Development QA
This is an excellent opportunity to lead the QA of Lundbeck's CMC vendor management program while contributing to the development of innovative treatments for brain diseases. As a key program owner, you will drive the continuous development of the vendor management program, including training colleagues.
We offer a challenging job with a mix of tasks that ensure compliant vendor oversight of Lundbeck's CMOs for clinical trials. CMC supports Lundbeck's pipeline from early to late phase, including biologics and small molecules.
Your new role – why is this a great opportunity
You will join a growing department with exciting future prospects supporting Lundbeck's pipeline and potential acquisitions. As our new colleague, you will ensure patient safety and GMP/GDP compliance of the CMOs supplying IMP for clinical trials. As Vendor Manager, you will be QA responsible for the vendor management program.
Tasks:
- QA owner of the vendor management program, including authoring of procedures
- Ensure audit plans and vendor oversight activities are planned and executed timely
As our new Senior Vendor Specialist, you will collaborate with multiple stakeholders in CMC and vendors worldwide. You will contribute to the continued development of the Quality Management System by authoring and approving SOPs governing activities.
Your future team
You will report to the Senior Director of CMC Development QA and collaborate with peers in QA, consultants, and Line of Business. You will have the opportunity to impact current ways of working and improve vendor management processes.
The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US, responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologics drug candidates, including device activities.
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
- Experience with vendor management
- Previous experience in performing audits would be an asset
- 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.
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