Vice President, Pharma Biotech Quality Systems

Phone: +1 202.822.1850
Country: United States

George Toscano has more than 20 years of experience helping companies in the global pharmaceutical, biologic and biotechnology markets develop and execute comprehensive quality systems solutions. He is a recognized data integrity expert and has conducted numerous audits and assessments to evaluate companies’ systems. In addition, he has led remediation activities related to data integrity deficiencies to help clients address regulatory enforcement actions.

As Vice President of Quality Systems, Mr. Toscano assists companies in the pharmaceutical, biologic and biotechnology industries, both foreign and domestic, in developing compliant quality and regulatory strategies. He also specializes in conducting GMP assessments of facilities and support to help companies address quality system deficiencies.

Mr. Toscano's technical background and broad range of experience includes validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances and cGMP (Good Manufacturing Practice) training. He has provided hundreds of companies with expert counsel on laboratory and manufacturing investigations, CAPA (corrective and preventative action) development and implementation, training, stability programs and other quality systems. He also has served as project lead and expert consultant on compliance initiatives involving corporate 483 responses, warning letters, consent decrees and application integrity policies (AIP).

Mr. Toscano previously served as the Director of Quality Control and R&D for several pharmaceutical and biotechnology companies, including Becker & Associates Consulting, and has coordinated analytical activities and method development processes and procedures in accordance with FDA and other regulatory agency requirements.