Shionogi Inc.
Florham Park, NJ
Overview The Associate Director, GCP Quality Assurance provides senior-level quality oversight for Shionogi's clinical development activities, ensuring compliance with ICH, FDA, EMA, PMDA, MHRA, and other global regulatory requirements. Serving as the QA representative and advisor to assigned study teams, this role evaluates processes, practices, documentation, and study plans to identify compliance risks and drive resolution of quality issues.The incumbent plans, conducts, and manages risk-based audits of investigator sites, CROs, vendors, and internal processes, ensuring timely and effective CAPA implementation. They support regulatory inspection readiness, provide regulatory interpretation to mitigate risks and address potential compliance concerns.Working with cross-functional partners and external vendors, the Associate Director drives risk mitigation strategies to safeguard patient safety, data integrity, and product quality. The role also contributes to the development,...