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Michael Schwartz Location
Chelmsford, MA, US
Michael Schwartz Work
Head of Quality Assurance @ (January 2022 - Present)
Head of Quality Assurance @ Curadel, LLC (June 2021 - December 2021)
Head of Quality Assurance @ (January 2021 - June 2021)
Senior QA Consultant @ Pharmaceutical and Medical Devices (August 2020 - December 2020)
Senior QA Director @ Translate Bio (May 2018 - August 2020)
Director QA @ Concert Pharmaceuticals, Inc. (November 2015 - May 2018)
QA - consultant @ (August 2015 - November 2015)
Consultant @ (September 2015 - October 2015)
QA Director @ AKPA (June 2012 - July 2015)
Assoc. Director @ Ziopharm Oncology (May 2011 - June 2012)
QA Mgr @ (April 2002 - November 2010)
Michael Schwartz Education
Boston University School of Medicine
Certificate (Clinical Trials)
2008-2009
University of Miami
MS (Biomedical Engineering)
Brandeis University
Bachelor of Arts (B.A.) (Biology, General)
Michael Schwartz Skills
21 CFR Part 11
Aseptic Processing
Batch Records
Biopharmaceuticals
Biotechnology
CAPA
CMO management
CRO
CRO Management
CTMS
Change Control
Clinical Development
Clinical Trials
Combination Products
Complaint Management
Compliance
Computer System Validation
Cross-functional Team Leadership
Cross-team Collaboration
Design Control
Deviations
Drug Development
Electronic Document Management System (EDMS)
Equipment Qualification
External Audits
FDA
FMEA
GCP
GLP
GMP
Good Clinical Practice (GCP)
Good Manufacturing Practices
GxP
Hosting Inspections
IND
ISO 13485
Leadership
Life Sciences
Lifesciences
MDRs
Management Review
Medical Devices
Oncology
Out of Spec
Pharmaceutical Industry
Pharmacovigilance
QMS
QP
Quality Agreements
Quality Assurance
Quality Auditing
Quality Operations
Quality System
Regulatory Affairs
Regulatory Requirements
Regulatory Submissions
Root Cause Analysis
SOP
Small Molecules
Supply Chain Management
Team Building
Technology Transfer
Training
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
V&V
Vaccines
Validation
mRNA
mRNA&LNP
Michael Schwartz Summary
Michael Schwartz, based in Chelmsford, MA, US, is currently a Head of Quality Assurance at Orna Therapeutics. Michael Schwartz brings experience from previous roles at Curadel, LLC, Ascentage Pharma, Pharmaceutical and Medical Devices and Translate Bio. Michael Schwartz holds a 2008 - 2009 Certificate in Clinical Trials @ Boston University School of Medicine. With a robust skill set that includes 21 CFR Part 11, Aseptic Processing, Batch Records, Biopharmaceuticals, Biotechnology and more. Michael Schwartz has 2 emails and 1 mobile phone numbers on RocketReach.
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