Kesley Gallagher
Global Operations Director at Amgen
- Role
- Director Global Operations, Nplate, Avsola, and Kanjinti at Amgen
- Location
- Ventura County, CA, US
- LinkedIn followers
- 500 followers
Experience
Director Global Operations, Nplate, Avsola, and Kanjinti
Nov 2019 — Present · Thousand Oaks, CA, US
Education
Bowdoin College
BA, Biology/Chemistry
1990 — 1994
University of Southern California
MS, Regulatory Science
2008 — 2010
Stanford University
Executive Education: Leadership Development
2020
Stanford University
Executive Program for Women Leaders, 2018, Business Administration and Management, General
Skills
- Product Development
- Regulatory Submissions
- Iso 13485
- Design Control
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Fda Submissions
- Medical Devices
- Capa
- Ce Marking
- Compliance
- Change Control
- 21 Cfr Part 11
- Cross-Functional Team Leadership
- Iso 14971
- Gmp
- Regulatory Affairs
- Quality System
- Quality Systems
- V&V
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