Senior QA Specialist for CMC Development

3 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

Senior QA Specialist for CMC Development

This is a unique opportunity to lead the QA of the Lundbeck CMC vendor management program while contributing to the development of innovative treatments for brain diseases.

We offer an exciting job with a broad variety in your daily work ensuring compliant vendor oversight of Lundbeck CMOs for clinical trials. CMC supports Lundbeck's current pipeline from early stage to late phase including both small molecule and biologics.

Your new role - why is this a great opportunity

As our new colleague, you will support the progression of our pipeline of promising drug candidates by ensuring 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

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, consultants, and Line of Business. You will have a great opportunity to impact current ways of working and improving the vendor management processes.



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