John Gormley Email & Phone Number
Director of Product Design and Development @ Fujirebio Europe
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John Gormley Location
- Seguin, TX, US
John Gormley Work
- 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 5 mobile phone numbers on RocketReach.
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