Senior QA Manager for Pharmaceutical Development Projects
3 days ago
At Novo Nordisk, we are dedicated to delivering high-quality products that meet the needs of our patients. As a Senior QA Manager for Pharmaceutical Development Projects, you will play a critical role in ensuring the quality and safety of our late stage development projects.
Key Responsibilities:- Ensure quality oversight and risk assessment for development projects approaching launch
- Plan, coordinate, and track QA project activities in collaboration with relevant area QAs
- Integrate quality aspects into project strategies, development plans, and validation strategies
- Proactively address potential quality drift in development projects
- Contribute to and endorse project strategies
To be successful in this role, you will need to have a master's or PhD degree within a relevant field of scientific expertise such as Chemistry, Chemical Engineering, Pharmacy, Biology or similar. You should also have several years' solid experience in the drug-oriented fields such as drug substance, drug product, QA or production within the pharmaceutical industry.
Additionally, you will need to have in-depth or specialist experience with GMP guidelines and regulations. You should also have experience in process technical transfer and/or validation, underscoring expertise in critical areas. Full English proficiency is required.
About the Department:
The Product Development (PD) QA department is a new area in Product Supply Quality and IT 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.
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