Tammy Gauthier
Director of Quality
- Role
- Director of Quality at Curadel Pharma
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Tammy Gauthier
QA professional with successful QMS oversight and implementation to support phase appropriate Investigational drug development, GMP, GCP, IND, NDA, Pre-Clinical, Clinical and Commercial phase medicinal product launch. Strong emphasis in Quality Assurance practices, Quality Management Systems and implementation. Vendor Management, Audits and Qualification of external operations CDMO, cGMP Batch record review, release and assemble Forma package to support QP CoR for Phase I/Phase Support and manage CTIS RFIs gateway and regulatory submissions (clinicaltrials.gov). Oversight of eTMF and CTMS. MS Regulatory Affairs for Drugs, Biologic\'s and Medical Devices
Experience
Director of Quality
Jun 2024 — Present · MA, US
Education
University of Massachusetts Lowell
Bachelor's Degree, Mechanical Engineering
Northeastern University
Master's Degree MS, Regulatory Affairs for Drugs, Biologics, and Medical Devices
2015 — 2018
Skills
- Autocad
- Design for Manufacturing
- Fda
- Electronics
- U.s. Food and Drug Administration (Fda)
- Design of Experiments
- Manufacturing
- Product Design
- Manufacturing Engineering
- Pro Engineer
- Documentation
- Iso 13485
- Cad
- Medical Devices
- Quality System
- R&D
- Testing
- Gd&T
- Mechanical Engineering
- Research and Development (R&D)
- Solidworks
- Spc
- Geomagic Qualify
- Fmea
- Root Cause Analysis
- Product Development
- Design Control
- Engineering
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