Senior Vendor Specialist, CMC Development QA

Senior Vendor Specialist, CMC Development QA

This is a great opportunity for an international position as the QA lead of the Lundbeck CMC vendor management program while contributing to the development of new innovative treatments for brain diseases. You will have a key role as program owner driving the continuous development of CMC´s vendor management program including training of colleagues.

We offer an exciting job with a broad variety in your daily work ensuring compliant vendor oversight of Lundbeck CMO´s 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

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 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

As our new Senior Vendor Specialist 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 SOP´s 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.   

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. You will be working in the DK time zone form our office in Valby. Most of our manufacturing and QC activities are outsourced to CMO´s.  

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. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

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 phone +45 30 83 21 69. Applications must be received by December 6th 2024. 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.

Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.