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Director, R & D Quality, Global RD / PV QA
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- With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
- Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team. Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business areas.
- Ensure proactive representation of Quality professionals at strategic project team and at GCP strategic discussions.
- Interact with senior Oncology Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
- The respective Data Management groups and respective CROs in order to ensure high data quality and proactive detection and resolution of issues.
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