Jason J. Ohare
Senior Director of Regulatory Affairs and GLBL GMP Quality Operations EMD at Charles River Laboratories
- Role
- Senior Director Regulatory Affairs and Global Quality Systems Microbial Solutions at Charles River Laboratories
- Location
- Charleston County, SC, US
- LinkedIn followers
- 500 followers
About Jason J. Ohare
Experienced GLBL Senior Director Quality /Regulatory Affairs with over 25 years\' experience (US and international) in the biotechnology/ device industry. Skilled in U.S. Food and Drug Administration (FDA) and numerous FDA filings and new product applications, Regulatory Strategy (EU and FDA), Quality Control, Quality Systems, ISO, Good Laboratory Practice and (GMP), QbD and Risk Management, Corrective and Preventive Action (CAPA), etc. Graduated Pre-Med BS Biology (Creighton University) and obtained MS Regulatory Affairs (Northeastern University). RAPS/RAC. Career began in QC Microbiology (9 years) Testing and new product implementations/validations which has proven useful during the transition to Sr. Management/ Corp. Leadership positions. Specialize in QS and Regulatory Strategy and new product authorizations (PMA, BLA, IND), and moderate to major change approvals.
Experience
Senior Director Regulatory Affairs and Global Quality Systems Microbial Solutions
Nov 2022 — Present · Charleston, SC, US
Education
Creighton University
BS Biology, Pre-Medicine/Pre-Medical Studies
1992 — 1997
Northeastern University
MS Regulatory Affairs-Biologics, Drugs, and Medical Devices
2011 — 2015
La Salle Academy
HS Diploma, College Prep
1988 — 1992
University of Rhode Island
MS Lab Sciences
2004 — 2006
Skills
- Lims
- In Vitro
- Glp
- Pharmaceutical Industry
- Sop
- Fda
- Capa
- Regulatory Affairs
- Quality Control
- Gmp
- Corrective and Preventive Action (Capa)
- Validation
- U.s. Food and Drug Administration (Fda)
- Vaccines
- Biotechnology
- Laboratory
- Biopharmaceuticals
- Microbiology
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