Manager, Quality Assurance sought by Parexel International in Waltham, MA to be responsible for the development & regular adjustment of a risk-based strategy for assessing & verifying compliance with GxP standards.

Requirements: Master's degree in Clinical Research, Medical Science, or a related field plus 2 years of quality assurance auditing experience in: Preparing & hosting Sponsor Audits & Regulatory Authority Inspections for clinical research trials; FDA 21 CFR Part 11 regulated environment; ICH-GCP & SOP guidelines; Phase I, II, & III clinical trials; GxP & pharmacovigilance audit consulting for internal & external clients; & clinical trials involving oncology, pediatrics, cardiology, gastroenterology, gynecology, hematology, endocrine/metabolism, allergy & clinical immunology, & neurology. Position is decentralized from Headquarters in Waltham, MA & may work from home anywhere in the U.S. Will travel to various & unanticipated worksites throughout the U.S.