Associate Director, Clinical Quality Management
Kyowa Kirin North America(1 day ago)
About this role
The Associate Director, Clinical Quality Management is the central RBQM lead for Clinical Operations at Kyowa Kirin, responsible for enterprise-wide proactive risk management across clinical trials. The role owns the end-to-end RBQM framework and a centralized clinical risk library to ensure consistent risk management across studies, programs, vendors, and regions. It partners cross-functionally to embed risk-based decision-making in study design, execution, oversight, and continuous improvement in alignment with ICH E6 (R3) and global regulatory expectations.
Required Skills
- Risk Management
- RBQM
- Centralized Monitoring
- Quality Oversight
- Vendor Oversight
- KRIs
- QTLs
- CAPA Management
- Audit Readiness
- Data Analytics
+4 more
Qualifications
- Bachelor's Degree in Life Sciences, Pharmacy, Nursing, or Public Health
- Advanced Degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (Preferred)
About Kyowa Kirin North America
kyowakirin.comKyowa Kirin is a Japanese biopharmaceutical company that develops innovative specialty medicines, with a particular focus on antibody‑based therapies for cancer, kidney disease, and immune‑mediated disorders. The company pursues technology‑driven drug discovery across biologics and small molecules and maintains a broad global network of research, development, and commercial operations. Kyowa Kirin advances a pipeline through internal R&D and strategic partnerships (including biologics and CDMO collaborations) to bring life‑changing treatments to patients. It emphasizes patient‑centred value, scientific expertise, and sustainability in its mission to raise health and well‑being worldwide.
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