Lead QA Specialist for Global CMC Vendor Management
3 weeks ago
About the Company
Lundbeck is a global pharmaceutical company with a rich history of innovation and commitment to improving the lives of people affected by brain diseases. Our mission is to deliver life-changing treatments and make a meaningful difference in the lives of our patients.
We are seeking a highly skilled and experienced Lead QA Specialist to join our CMC Development QA team. This is an exciting opportunity to work in a dynamic and collaborative environment, contributing to the development of new innovative treatments for brain diseases.
About the Role
The Lead QA Specialist will be responsible for leading the vendor management program, ensuring compliant vendor oversight of Lundbeck CMOs for clinical trials. This includes authoring and approving SOPs governing vendor activities, ensuring audit plans and vendor oversight activities are planned and executed timely.
This is a key role in our CMC Development QA organization, working closely with multiple stakeholders in CMC and vendors worldwide. The successful candidate will have a strong background in quality assurance, with experience in vendor management and auditing.
Key Responsibilities
- Lead the vendor management program, including authoring and approving SOPs
- Ensure compliant vendor oversight of Lundbeck CMOs for clinical trials
- Plan and execute audit plans and vendor oversight activities timely
Requirements
- Masters degree in pharmacy, chemistry, biology, or similar qualification
- Experience in vendor management and auditing
- Fluent in English
Benefits
Lundbeck offers a competitive salary of $120,000 - $150,000 per annum, depending on experience. We also offer a range of benefits, including health insurance, retirement plan, and opportunities for professional development.
About the Location
The role will be based in Copenhagen, Denmark, working in the DK time zone from our office in Valby. We offer a unique opportunity to work in a global pharmaceutical company, contributing to the development of new innovative treatments for brain diseases.
How to Apply
If you are a highly skilled and experienced QA professional looking for a new challenge, please upload your CV and a few lines about your motivation for applying. We look forward to hearing from you
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