Quality Assurance Expert in Pharmaceutical Integration
3 days ago
The CMC Quality Integration Specialist will be responsible for the following:
- Acting as Sub Stream Lead for the integration of acquired CMC QA functions (people, processes, and procedures) in the quality workstream across Novo Nordisk.
- Providing CMC QA advice and directions to the integration strategies and transition activities during due diligence and merger & acquisitions.
- Sets new standards and processes for quality integration of corporate assets into the Novo Nordisk pipeline.
- Brings 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.
- Supports the integration projects in the quality assessment of the full supply chain to identify quality gaps, opportunities, and risks.
The ideal candidate will have a master's degree or Ph.D. in Pharmacy, Chemistry, Biology, Engineering, or similar and extensive experience in CMC, QA, or production-related roles. They will also have gained experience within the pharmaceutical industry and have in-depth knowledge of the pharmaceutical product value stream and expertise in GxP regulations and guidelines (EU and US). Fluency in English, both written and spoken, is required. On a personal level, the successful candidate will have a structured way of working, be solution-oriented, and have a can-do attitude. They will also have an outgoing and self-driven personality, take the initiative, be agile, and embrace new ways of working. Excellent communication skills will allow them to engage at all levels of the organization, act proactively, and make independent decisions.
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