Compliance QA Manager

Job description

SUMMARY/JOB PURPOSE: The Compliance QA Manager, QA Core, is responsible for coordinating and maintaining inspection readiness activities and provides support for assessing proposed corrective and preventive actions in response to inspection findings. This role supports continuous improvement efforts within the Inspection Management program to enhance quality standards and operational efficiency. ESSENTIAL DUTIES/RESPONSIBILITIES: Manage inspection logistics to support regulatory inspections, third-party audits, and mock inspections at Exelixis, including notification process, logistics team, inspection room preparation, and records management. Identify and drive improvements in the inspection readiness tools, templates and training material for inspection team and subject matter experts. Manage all inspection related documentation including inspection notifications, document requests, presentations and storyboards, and tools within the validated inspection system and centralized document repository. Coordinate and provide assessment of functional area inspection observation responses and associated CAPAs. Support the coordination of clinical site inspection logistics with the diffe...