Sean Smith Email & Phone Number
Vice President, Head of Quality @ RhyGaze AG
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Sean Smith Location
- Boston, MA, US
Sean Smith Work
- 2026 -now Vice President, Head of Quality @
- 2023 -2026 Vice President, Head of Quality @
- 2023 -2023 Vice President, Head of Quality and Validation @ Oxford Biomedica (Formerly Homology Medicines)
- 2022 -2022 Sr. Director, Head of Quality @ Oxford Biomedica Solutions
- 2021 -2022 Sr. Director, GMP QA and Validation @ Homology Medicines, Inc.
- 2018 -2020 Director, GMP Quality Assurance and Validation @ Homology Medicines, Inc.
- 2017 -2018 Associate Director, Quality Systems and Compliance @
- 2016 -2017 Sr. QA Manager - Quality Systems, Validation, and Risk Management @
- 2015 -2016 QA Sr. Specialist - Quality Systems @
- 2014 -2015 QC Specialist - Contract Testing and Product Metrics Lead @
- 2012 -2014 QA Specialist - Quality Systems and Validation @
- 2008 -2012 Manager - Validation and Quality Systems @
- 2001 -2008 Lead QC Sr. Analyst @
Sean Smith Education
- Northeastern University
Master of Science (MS) (Regulatory Affairs)
2008-2010 - University of California, San Diego
Bachelor of Science (BS) (Biochemistry and Cell Biology)
1996-2000 - Northeastern University
Master of Business Administration (MBA) (Business Administration and Management, General)
Sean Smith Skills
- Validation
- GMP
- Quality System
- Quality Assurance
- Change Control
- Quality Control
- Computer System Validation
- CAPA
- FDA
- Biotechnology
- 21 CFR Part 11
- SOP
- Biopharmaceuticals
- Empower
- Change Management
- Software Implementation
- System Administration
- Laboratory Skills
- Quality Management
- LMES
- Process Improvement
- LIMS
- CCMS
- Template Building
- CIMS
- Performance Improvement
- cGMP practices
- Regulatory Requirements
- Trackwise
- Pharmaceutical Industry
- Standard Operating Procedure (SOP)
- Program Implementation
- Staff Development
- Staff Management
- Equipment Qualification
- ICH guidelines
- Good Clinical Practice (GCP)
- Laboratory Information Management System (LIMS)
- System Deployment
- Risk Management
- Leadership
- Good Clinical Practice Gcp
- Agile Methodologies
- Engineering
- Laboratory Information Management System Lims
- Microsoft Excel
- Management
- Standard Operating Procedure Sop
- Project Management
- Customer Service
- Microsoft Office
- Standard Operating Procedure
- Good Clinical Practice
- Laboratory Information Management System
Sean Smith Summary
- Sean Smith, based in Boston, MA, US, is currently a Vice President, Head of Quality at RhyGaze. Sean Smith brings experience from previous roles at KSQ Therapeutics, Inc., Oxford Biomedica (Formerly Homology Medicines), Oxford Biomedica Solutions and Homology Medicines, Inc.. Sean Smith holds a 2008 - 2010 Master of Science (MS) in Regulatory Affairs @ Northeastern University. With a robust skill set that includes Validation, GMP, Quality System, Quality Assurance, Change Control and more. Sean Smith has 2 emails on RocketReach.
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