Ellen Kawata
Senior Director, R&D Quality at Moderna
- Role
- Senior Director, Inspection Management & Regulatory Intelligence at Moderna
- Location
- Irvine, CA, US
- LinkedIn followers
- 500 followers
About Ellen Kawata
Experienced Global Quality Assurance leader. Expertise in Inspection Management, supporting GCP, GVP, GLP Regulatory Agency inspections and leading global cross-functional submission teams through inspection readiness and preparation activities. Extensive experience with global study management, oversight of CROs and clinical vendors and ensuring clinical program activities are conducted in compliance with applicable SOPs and regulations.
Experience
Senior Director, Inspection Management & Regulatory Intelligence
Oct 2022 — Present
Education
San Diego State University
Bachelor’s Degree, Health Sciences
Skills
- Gcp
- Pharmaceutical Industry
- Sop
- Fda
- Ctms
- Regulatory Submissions
- Ich-Gcp
- Biotechnology
- Good Clinical Practice (Gcp)
- Clinical Trials
- CRO
- Regulatory Affairs
- Japanese Culture
- Project Management
- CRO Management
- Clinical Development
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