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Alexandra Dilis spearheads the Quality Systems function at Integrium - comprised of Clinical Quality Assurance and Internal Quality Compliance sub-functions. She is responsible for maintaining regulatory compliance of clinical trials and managing internal Quality Systems. Specifically, Ms. Dilis’ responsibilities include facilitating and hosting FDA and Sponsor inspections. In addition, she is responsible for managing Integrium’s Standard Operating Procedure (SOP) system, internal auditing, facilitating computer systems validation projects, and vendor qualification. She is also responsible for managing site, central laboratory, SMO, and vendor auditing programs within the scope of clinical programs and on behalf of Integrium’s clients. Alexandra has more than 13 years of quality assurance experience in the pharmaceutical, biotechnology, and medical devise industries. Prior to joining Integrium, Alexandra was the Director of Quality Systems with a contract testing and auditing laboratory. Previously, she held key quality assurance roles in two CROs, a pre-clinical development laboratory, and a major biotech company. In these positions, she managed and actively participated in all aspects of the Quality Assurance function of these organizations. Alexandra’s selected achievements include successful implementation of the document control, Good Laboratory Practice (GLP) standards, and ISO 9001:2000 systems, as well highly effective management of 21 CFR 11 compliance programs. Alexandra earned her Bachelors of Science degree in Business Management from Providence College and her Juris Doctor degree from the New England School of Law in Boston. | 