Mandy Gervasio Email & Phone Number
Chief Risk and Compliance Officer @ Comanche Biopharma
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Mandy Gervasio Location
- Dartmouth, MA, US
Mandy Gervasio Work
- 2025 -now Chief Risk and Compliance Officer @
- 2021 -2025 Vice President QA and Compliance @
- 2018 -now President and Owner @
- 2018 -now Automating Quality Podcast Show Host @
- 2020 -2021 Director Quality Compliance @
- 2018 -2019 Vice President, Quality and Compliance @
- 2017 -2018 Business Development Manager @
- 2018 -now Automating Quality Podcast Show Host @
- 2015 -2017 Principal Consultant, Risk and Compliance Advisory Services @
- 2014 -2015 Lead Quality Project Engineer- Commercial Inhalation Expansion @
- 2013 -2014 Senior .Quality Consultant, Consent Decree Remediation @
- 2012 -2012 QA Manager, Laboratory Analytics @ Exemplar Pharmaceuticals/Laboratories, LLC
- 2011 -2012 Senior Quality Specialist- CMC Change Management @
- 2008 -2011 Senior Business Systems Analyst- Cqo Quality Systems @
- 2007 -2008 QA Operations Specialist @
- 2006 -2007 QA Associate and External Commercial @
- 2005 -2006 Manufacturing Associate-Cell Culture @
- 2004 -2005 Fermentation Associate @
- 2002 -2004 Manufacturing Associate-Bioprocess Operations @
- 2002 -2004 Purification Associate @
Mandy Gervasio Education
- MIT Sloan School of Management
Certification (Business Analytics)
2020-2020 - Six Sigma Global Institute
Lean Six Sigma Black Belt Certification
2018 - Stanford University
Graduate Certification (Risk Based Decision Making)
2013 - Northeastern University
Master of Science (Leadership; Project Management)
2008-2010 - University of Massachusetts
Bachelor of Science (Biology)
1997-2002
Mandy Gervasio Skills
- GMP
- Change Control
- FDA
- Sop
- Validation
- Biotechnology
- CAPA
- Quality System
- 21 CFR Part 11
- Trackwise
- Pharmaceutical Industry
- Aseptic Processing
- Regulatory Affairs
- Technology Transfer
- GxP
- Purification
- Quality Control
- Quality Assurance
- Continuous Improvement
- V&V
- Manufacturing
- Cross-functional Team Leadership
- Vaccines
- Regulatory Requirements
- Corrective and Preventive Action (CAPA)
- U.S. Food and Drug Administration (FDA)
- Standard Operating Procedure (SOP)
- U.S. Title 21 CFR Part 11 Regulation
- Verification and Validation (V&V)
- Business Process Improvement
- Computer System Validation
- Continuous Process Improvement
- Quality Management
- Quality Auditing
- Business Relationship Management
- Business Development
- Consulting
- Computerized System Validation (CSV)
- Software as a Service (SaaS)
- Good Manufacturing Practice (GMP)
- Global Regulatory Compliance
- Relationship Building
- Risk Management
- Auditing
- Regulatory Documentation
- Data Analysis
- Data Integrity
- Business Strategy
Mandy Gervasio Summary
- Mandy Gervasio, based in Dartmouth, MA, US, is currently a Chief Risk and Compliance Officer at Comanche Biopharma. Mandy Gervasio brings experience from previous roles at Comanche Biopharma, MG Quality Solutions Group LLC, SOLABS and Acorda Therapeutics, Inc.. Mandy Gervasio holds a 2020 - 2020 Certification in Business Analytics @ MIT Sloan School of Management. With a robust skill set that includes GMP, Change Control, FDA, Sop, Validation and more. Mandy Gervasio has 2 emails and 2 mobile phone numbers on RocketReach.
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Mandy Gervasio
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