Head of Quality Assurance @ (September 2016 - March 2020)
Vice President, Quality Assurance @ (October 2013 - September 2016)
Sr. Director Quality Assurance @ (August 2010 - April 2013)
Director Quality Systems @ (February 2008 - July 2010)
Associate Director Validation (OCN) @ (January 2005 - January 2007)
Sr. Manager Validation (OCN) @ (January 2002 - January 2005)
Associate Manager Validation @ (January 1996 - January 2002)
Regulatory Affairs Associate @ (January 1993 - January 1996)
Validation Engineer @ John Brown E&C (January 1991 - January 1993)
Patrick Smith Education
Trinity College, Dublin 2009-2010
Alliant International University
(Management)
2004-2007
University Of California - Los Angeles
(Management)
1994-1996
Rochester Institute of Technology
Bachelor of Science (Engineering)
1988-1991
SGF High School
University Of California - Berkeley
Patrick Smith Skills
CAPAs
Validation
CAPA
V&V
FDA
GxP
Regulatory Affairs
Cleaning Validation
GMP
Regulatory Submissions
Six Sigma
Quality Assurance
Change Control
HPLC
GAMP
Trackwise
21 CFR Part 11
Quality Auditing
Quality Control
Lifesciences
GCP
Pharmaceutics
Vaccines
FDA GMP
Aseptic Processing
Biotechnology
Deviation Management
Design Control
Quality System
Contract Manufacturing
Sop
Quality Management
Biopharmaceuticals
Computer System Validation
R&D
ISO 13485
Clinical Trials
GLP
Chromatography
Regulatory Requirements
Iso 9000
ISO
Medical Devices
Technology Transfer
Root Cause Analysis
Analytical Chemistry
Pharmaceutical Industry
Manufacturing
LIMS
Drug Development
Sales
Microsoft Office
Microsoft Excel
Customer Service
Management
Project Management
Change Management
Pharmaceutical Sales
Product Launch
Public Speaking
Business Strategy
Patrick Smith Summary
Patrick Smith, based in California, United States, is currently a Vice President, Quality Assurance at Protagonist Therapeutics. Patrick Smith brings experience from previous roles at Kodiak Sciences, MyoKardia, Anacor Pharmaceuticals and Elan. Patrick Smith holds a 2009 - 2010 Trinity College, Dublin. With a robust skill set that includes CAPAs, Validation, CAPA, V&V, FDA and more. Patrick Smith has 4 emails and 3 mobile phone numbers on RocketReach.
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