Senior GCP QA Leader - Compliance & Audit Excellence

Shionogi Inc. is seeking an Associate Director, GCP Quality Assurance to provide senior-level quality oversight for clinical development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA and other global requirements. You will lead risk-based audits of investigator sites, CROs, vendors, and internal processes, drive CAPA resolution, and support regulatory inspection readiness.