SUMMARY/JOB PURPOSE:

This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.

Essential Duties And Responsibilities:

• Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.

• Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Syst...