2007 -2011 Director of Quality Management and Clinical Quality Records and Information Management @
2005 -2007 Sr. Manager Research Operations @
2002 -2005 Manager Corporate Quality @
2001 -2002 Associate Director Quality Systems @ Research Scientists Inc
1992 -2001 Sr. Project Manager and Chemist @
1987 -1992 Sr. Laboratory Lead @
1984 -1987 Sr. Technologist and GLP Study Investigator @
David O Education
University of Redlands
Business Information Systems
The University of Texas at Austin
(Biochemistry)
David O Skills
Six Sigma
GMP
Quality Assurance
Validation
FDA
21 CFR Part 11
Data Management
Regulatory Affairs
ISO
Change Control
V&V
Manufacturing
Clinical Development
Management
Laboratory
CAPA
Pharmaceutical Industry
Software Documentation
Protocol
Computer System Validation
Process Improvement
Project Management
Business Process Improvement
Testing
R&D
Quality System
GxP
Technology Transfer
Regulatory Requirements
Sop
GLP
Auditing
CRO
Clinical Research
Medical Devices
ISO 13485
SPC
Quality Control
Training
GAMP
CTMS
LIMS
Cross-functional Team Leadership
Regulatory Submissions
GCP
Strategy
Quality Management
Clinical Trials
Biotechnology
Quality Auditing
David O Summary
David O, based in United States, is currently a Sr. Director R and D Quality at Summit Therapeutics, Inc.. David O brings experience from previous roles at Cidara Therapeutics, Gossamer Bio, Iovance Biotherapeutics, Inc. and Spectrum Pharmaceuticals. David O holds a Business Information Systems @ University of Redlands. With a robust skill set that includes Six Sigma, GMP, Quality Assurance, Validation, FDA and more. David O has 2 emails and 2 mobile phone numbers on RocketReach.
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