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CMC QA Expert
3 weeks ago
We're seeking an exceptional CMC QA Expert to join our PDQ Integration team. This is an exciting opportunity to shape the future of quality integration within our organization and make a meaningful impact on patient care.
About the DepartmentPDQ Integration is a new team within Due Diligence & Integration Quality, focused on the quality integration of acquired corporate assets. As a member of this team, you'll be part of a dynamic group of professionals who share your passion for quality assurance and excellence.
Our department is characterized by a high level of professionalism, flexibility, and collaboration. We foster a culture of open communication, mutual respect, and continuous learning, where every voice matters.
About the Job
- You will act as Sub Stream Lead for the integration of acquired CMC QA functions, people, processes, and procedures, in the quality workstream across Novo Nordisk.
- You will provide CMC QA advice and directions to the integration strategies and transition activities during due diligence and merger & acquisitions.
- You will set new standards and processes for quality integration of corporate assets into the Novo Nordisk pipeline.
- You will bring your CMC and QA skills into play by solving complex quality issues, mitigating quality risks, and ensuring patient safety in the transition of acquired assets into Novo Nordisk.
- You will support the integration projects in the quality assessment of the full supply chain to identify quality gaps, opportunities, and risks.
About You
- You have a master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or a related field.
- With extensive experience in CMC, QA, or production-related roles, you bring a deep understanding of the pharmaceutical product value stream.
- Your expertise in GxP regulations and guidelines (EU and US) is second to none.
- You are fluent in English, both written and spoken.
