Senior Quality Lead – FSP

Job Description

Seeking a Third Party Quality Lead to manage vendor quality for Parexel's clinical trials. Key responsibilities include identifying and responding to GCP quality risks related to vendor and site engagement, leading quality discussions, and presenting quality perspectives. The role involves providing oversight reports, communicating critical quality information, validating action plans, and evaluating quality performance to drive continuous improvement and compliance with functional vendor oversight requirements.

Qualifications

1. Bachelor's degree with 7+ years of experience or equivalent. 2. Master's/MBA with 6+ years of experience or equivalent. 3. Minimum of 5 years of pharmaceutical experience with clinical trial development. 4. Strong knowledge in quality areas (audit, inspection, compliance, inspection readiness). 5. Experience in quality and compliance management, QC, Root Cause Analysis, risk identification, metrics development, and audit/inspection conduct. 6. Develop strategies using metrics to manage compliance. 7. Participate in cross-line global initiatives for quality process improvement.

Benefits

- Health insurance - Flexible working arrangements - Professional development opportunities