Mary Mazur-Melnyk, Ph.D. – Quality/Regulatory

Mary Mazur-Melnyk, Ph.D. – Quality/Regulatory

Dr. Mazur-Melnyk is focused on serving the healthcare industry in the areas of Quality/Regulatory Systems, and Process Transfer and Validation/Scale-Up.  She specializes in the areas of Pharmaceutical and Medical Devices (all Classes in FDA, Canadian, Australian and EU environments), Vaccines, In Vitro Diagnostics, Dental Healthcare Products, Disinfectant Drugs and Non-Clinical and Clinical Operations (Bioanalytical and Analytical Testing).

Dr. Mazur-Melnyk also lends her expertise to others as a Professor for AAPS (Academy of Applied Pharmaceutical Sciences – Ontario certified College and University) providing Post Graduate training dedicated to the healthcare industry requirements in areas of clinical trial management and regulatory affairs compliance.  Her past experience includes Custom Biologics (GLP and GCP bio-analytical laboratory) QA support since 2006 and her services have been secured by the Canadian Government Microbiology Laboratory in Winnipeg to establish a gap assessment to OECD and FDA CFR Part 58 GLPs.

Prior roles held were Vice President of Corporate Quality Operations and Regulatory Compliance Biovail Corporation, Senior Director of Quality Assurance and Quality Control Biomira, Director of Regulatory Affairs, R&D and Quality Operations (Medical Devices and Drugs) Novartis (CIBA Vision), Quality R&D Head Canada and  Co-Director of Project Control Office Technology Transfer Manager Pharmaceutical Sciences QA for GSK and various Quality positions within Sanofi Pasteur (Pasteur Merieux Connaught) 1990-1996.

Dr. Mazur-Melynk received her PhD in Molecular Biology/Biochemistry/Toxicology from York University , her M.Sc. in Medical Sciences from McMaster University Medical Center and her Honors B.Sc. in Biology/Microbiology from the University of Toronto.

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