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Senior QA Project Manager for Product Development and Quality Oversight
1 month ago
You will be responsible for ensuring quality oversight for development projects approaching first human dose and throughout the development towards launch. This includes planning, coordinating, and tracking QA project activities in collaboration with relevant operational QA departments.
As a senior QA Project Manager, you will act as QA Outsourcing Manager for externally produced development products, being the QA contact to Contract Manufacturing Organizations (CMO). You will also integrate quality aspects into project strategies and development plans, proactively addressing potential quality drift in development projects.
Qualifications
- You should hold a Master's or PhD degree within a relevant field of scientific expertise, such as Chemistry, Chemical Engineering, Pharmacy, Biology, or similar.
- Have at least 5 years of solid experience preferably within Novo Nordisk or other pharmaceutical company.
- Demonstrate experience in QA and Project Management within drug development.
- Experience from working with CMO's in GMP regulated environments.
- Proficiency in English in both written and spoken.
About the Team
Product Development (PD) QA is a new area in PSQIT established to gather all QA responsibilities for the Development Product Portfolio (DPP). The new organization will act as a QA single point of entry into PSQIT providing an end-to-end quality overview, ensuring the quality strategy for commercial scalability and manufacturability from early development to life cycle management.
DPP QA consists of approximately 25 highly skilled employees. You will become part of a department with many interfaces across the organization across Denmark and our international production sites.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first.
