QA Auditor II - Remote

Conduct complex internal and external Clinical Research Site audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines, and client contractual obligations. • Identify issues impacting the quality and/or integrity of clinical research programs, determine root cause of non-conformance and develops strategies to address issues. • Perform technical document review and other GCP practice activities in support of clinical development programs. • Provide audit reports to management. • Plan and deliver quality services including contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects. • Lead process/quality improvement initiatives. • Mentor peers. • Develop tools and other materials for tracking of compliance management activities and analyze trends. • Upon request, support regulatory inspections and/or client audit hosting.