2021 -now Director of Product Design and Development @
2009 -2016 General Manager @
2008 -2009 Director of Quality and Regulatory Affairs @
1992 -2008 VP of Quality Assurance and Regulatory Affairs @ American Biological Technologies, Inc.
1988 -1992 Director of Operations @ American Biological Technologies, Inc.
1983 -1987 Manager of Technical Production @
1980 -1983 Sr. Process Engineer @
1976 -1980 Assoc. Chemist and Chemist @
John Gormley Education
Siena College
Bachelor’s Degree (Biology)
1972-1976
Bergen Catholic HS
Academic (College Preparatory)
1968-1972
John Gormley Skills
FDA
Validation
Quality System
ISO 13485
Medical Devices
Quality Assurance
V&V
Regulatory Affairs
Design Control
Biotechnology
GMP
Contract Manufacturing
R&D
Quality Control
Iso 9000
Quality Management
CAPA
Product Development
Operations Management
Biopharmaceuticals
Quality Auditing
Pharmaceutical Industry
Cross-functional Team Leadership
Change Control
Technology Transfer
Product Transfer
Lifesciences
21 CFR Part 11
Manufacturing
Commercialization
Product Launch
Sop
ISO 14971
GLP
Clinical Trials
Immunology
ISO
Technical Support
LIMS
Immunoassays
21 CFR
Regulatory Requirements
Regulatory Submissions
Management
Clinical Development
Chromatography
HPLC
Process Transfer
B2B
Life Sciences
Distribution Logistics
Cross Functional Team Leadership
John Gormley Summary
John Gormley, based in Seguin, TX, US, is currently a Director of Product Design and Development at Fujirebio Diagnostics. John Gormley brings experience from previous roles at Fujirebio Diagnostics, Inc. and American Biological Technologies, Inc.. John Gormley holds a 1972 - 1976 Bachelor’s Degree in Biology @ Siena College. With a robust skill set that includes FDA, Validation, Quality System, ISO 13485, Medical Devices and more. John Gormley has 1 emails and 2 mobile phone numbers on RocketReach.
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