Senior Issue Lead - FSP

Job Summary

Parexel is looking for multiple Senior Issue Leads to join our team. Candidates can be based anywhere in Argentina, Mexico or Brazil! The Senior Issue Lead will be accountable for managing Quality Events and coordinating Audits & Inspections, overseeing root cause analysis, CAPA management, and ensuring compliance with GCP and regulatory requirements.

Responsibilities

• Quality Events
  • Manage confirmed Major/Critical Quality Event (QE) cases through investigation, root cause analysis, and communication.
  • Ensure investigations meet timelines, compliance, and documentation standards.
  • Direct QE team to propose Corrective & Preventative Actions and verify completion.
  • Handle complex cases requiring presentation to senior leaders as part of the Quality Review Team (QRT).
• Audits & Inspection Coordination
  • Drive GCP quality in the face of regulatory scrutiny, operational data,...