Quality Issue Lead - FSP

Parexel FSP is looking for Issue Leads in Brazil, Mexico, and Argentina!

Job Summary

The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which we conduct GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate team to perform interventions as needed. The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and / regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

Job Responsibilities

Quality Event Assessment and Investigation

This individual will be accountable for the review and classification of submi...