Joseph MacHi Email & Phone Number
Director Computer Systems Validation @ Virscio
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Joseph MacHi Location
- New York, NY, US
Joseph MacHi Work
- Director Computer Systems Validation @ (July 2023 - Present)
- Director Computer System Validation @ Formation Bio/Trialspark (September 2021 - July 2023)
- Senior Manager Integrated Quality Management @ (September 2020 - September 2021)
- Computer Validation Consultant SME Supporting the Clinical Quality Organization @ (May 2020 - September 2020)
- Associate Director Validation and QC, Data Services Oncology @ (March 2019 - May 2020)
- Program Director for Risk Management and Regulatory Compliance @ (January 2017 - March 2019)
- Associate Director for GQRC GMP Validation @ (May 2013 - December 2016)
- Manager EQ-Q Computer Validation @ (October 2011 - May 2013)
- Project Compliance and Validation Lead @ (December 2010 - October 2011)
- Managing Consultant, Computer Validation @ (November 2008 - December 2010)
- Director, GCP and GMP Quality Assurance, Novartis Consumer Health @ (January 2007 - October 2008)
- Associate Director of e-Compliance, Clinical Safety and Epidemiology @ (November 2004 - January 2007)
- Director of Validation Services, CIBA Vision @ (May 2002 - November 2004)
Joseph MacHi Education
- University of Detroit Mercy
Master (Management Computer & Information Systems Software Development,)
1992-1994 - St. John's University
BS (Computer Science)
1985-1987
Joseph MacHi Skills
- Validation
- Computer System Validation
- 21 CFR Part 11
- Pharmaceutical Industry
- Quality Auditing
- Document Management
- Regulatory Affairs
- Clinical Trials
- Software Documentation
- Quality Management
- V&V
- GMP
- GxP
- FDA
- Sop
- Lifesciences
- CAPA
- LIMS
- GCP
- Biotechnology
- Technology Transfer
- Change Control
- Quality System
- Clinical Research
- Quality Assurance
- GAMP
- Process Simulation
- Quality Control
- CTMS
- Clinical Development
- CRO
- GLP
- Protocol
- Testing
- Auditing
- SDLC
- Oncology
- ISO
- Regulatory Requirements
- Cross-functional Team Leadership
- Regulatory Submissions
- Cross Functional Team
- Data Validation
- Life Sciences
- Medical Devices
- Corrective and Preventive Action Capa
- Cross Functional Team Leadership
- Pharmaceutics
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Computer System
- R&d
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Corrective and Preventive Action
Joseph MacHi Summary
- Joseph MacHi, based in New York, NY, US, is currently a Director Computer Systems Validation at Virscio. Joseph MacHi brings experience from previous roles at Formation Bio/Trialspark, Flatiron Health, ADC Therapeutics and Eisai US. Joseph MacHi holds a 1992 - 1994 Master in Management Computer & Information Systems Software Development, @ University of Detroit Mercy. With a robust skill set that includes Validation, Computer System Validation, 21 CFR Part 11, Pharmaceutical Industry, Quality Auditing and more. Joseph MacHi has 1 emails and 4 mobile phone numbers on RocketReach.
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