Kelly Ohare
Biopharmaceutical/Cell & Gene Therapy Quality and Operations Executive Leader
- Role
- Vice President, Head of Quality at Engene
- Location
- Natick, MA, US
- LinkedIn followers
- 500 followers
About Kelly Ohare
Experienced senior biopharmaceutical executive with significant experience in various sized, staged- and funded-biotechnology and pharmaceutical companies. Hands-on and leadership experience ranges from early stage clinical through commercial. Champion of phase-appropriate Quality and production programs which compliment corporate objectives.Product experience includes biologics, small molecules, cell and gene therapies and diagnostic imaging agents both aseptically process and terminally sterilized. Direct global agency experience includes FDA and EMA, with several additional interactions across various other international agencies.Strong advocate of Quality by Design, Continuous Improvement and efficient Quality Management Systems. Proud contributor to the successful commercialization of several biologic and pharmaceutical products.
Experience
Vice President, Head of Quality
Jan 2024 — Present · Montreal, QC, CA
Education
Boston University
Bachelor of Science - BS, Biomedical and Clinical Sciences
Skills
- Gmp
- Quality Assurance
- Fda
- Technology Transfer
- Quality System
- Aseptic Processing
- Capa
- Trackwise
- Biopharmaceuticals
- Gxp
- Pharmaceutical Industry
- Change Control
- 21 Cfr Part 11
- Biotechnology
- Validation
- Sop
- Glp
- Lims
- V&V
- Deviations
- Regulatory Affairs
- Clinical Development
- Aseptic Technique
- Regulatory Requirements
- Iso 13485
- Gcp
- Pharmaceutics
- CRO
- Computer System Validation
- Regulatory Submissions
- Drug Development
- Lifesciences
- Contract Manufacturing
- Cgmp Practices
- Quality by Design
- Gamp
- Ind
- Life Sciences
- Vaccines
- Quality Auditing
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