Tammy Gauthier
Director of Quality @Curadel Pharma
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WORK HISTORY
Director of Quality @Curadel Pharma
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
SKILLS
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
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