Senior Vendor Specialist, CMC Development QA Transformation
2 weeks ago
About Lundbeck
Lundbeck is a global pharmaceutical company with a rich history of developing innovative treatments for brain diseases. Our mission is to bring life-changing therapies to patients in need.
Job Overview
We are seeking a highly skilled Senior Vendor Specialist to join our CMC Development QA team. This is an exciting opportunity to work on the development of new innovative treatments for brain diseases while contributing to the growth and success of our organization.
About the Role
In this role, you will be responsible for ensuring compliant vendor oversight of Lundbeck's Contract Manufacturing Organizations (CMOs) for clinical trials. You will have a key role as program owner driving the continuous development of CMC's vendor management program, including training of colleagues. Your expertise will be invaluable in shaping our quality management system and ensuring patient safety and GMP/GDP compliance.
Your Key Responsibilities
- QA owner of the vendor management program, including authoring of procedures
- Ensure audit plans and vendor oversight activities are planned and executed timely
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. As a valued member of our team, you will contribute to our continued development of the Quality Management System by authoring and approving SOPs governing the activities.
The Ideal Candidate
We are looking for a seasoned professional with a master's degree in pharmacy, chemistry, biology or similar qualification. Previous experience in performing audits would be an asset. Fluency in English is required, and we welcome applications from international candidates.
What We Offer
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.
Educational Background and Work Experience
- 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
Salary and Benefits
The salary for this position is approximately $85,000 - $110,000 per year, depending on qualifications and experience. In addition to a competitive salary, we offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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