About this role
Reporting to the Regional Quality Assurance Director, this role will ensure that highest standards of data quality and study participant safety are maintained, as well as adherence to study protocols, CenExel SOPs, Site Working Practices (WPs), ICH GCP, Code of Federal Regulations, and IRB Guidelines. This role will ensure that accepted procedures are followed. Quality Assurance establishes and maintains quality metrics and trends for the site in collaboration with site leadership. These include but are not limited to Quality control oversight, deviations, CAPAs, audit findings, management of the internal audit program, training compliance, vendor management, risk management and documentation control.