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Leading QA Specialist for Vendor Management in CMC Development
1 month ago
At Lundbeck, we are seeking an experienced QA Specialist to lead our vendor management program in CMC Development. As a key member of our team, you will play a crucial role in ensuring compliant vendor oversight of our Contract Manufacturing Organizations (CMOs) for clinical trials.
We offer an exciting opportunity to work with a broad range of tasks, including authoring procedures, planning and executing audit plans, and collaborating with multiple stakeholders across the globe. Your expertise will be essential in driving the continuous development of our Quality Management System by creating and approving Standard Operating Procedures (SOPs).
As our new Senior Vendor Specialist, 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 a great 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 supporting the development of Small Molecule and Biologics drug candidates. You will work in the DK time zone from our office in Valby.
Our ideal candidate holds a master's degree in pharmacy, chemistry, biology, or similar qualification, with experience in vendor management and previous experience in performing audits as an asset. Fluency in English is required.
Lundbeck offers a unique position for you to build upon your experiences and professional development. We provide a mix of exciting tasks, numerous development opportunities, and initiatives focused on your well-being. The estimated salary for this position is approximately **$120,000 - $180,000** per year, depending on location and experience.
