The Director, Regional Clinical Compliance and Inspection Management, is responsible for driving proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials. The role provides leadership and oversight to ensure consistent implementation of GCP and regulatory requirements, effective inspection readiness programs, and successful management of inspections and audits.
Key responsibilities include leading inspection readiness and audit support activities at regional or global levels, guiding clinical teams on inspection expectations, coordinating audit and inspection responses, and ensuring timely, high-quality, and compliant remediation. The role also drives a proactive inspection/audit readiness culture, to effectively manage complex, high-risk inspections while maintaining continuous readiness.
This role supports inspection and audit management across the JAPAC region, working in close collaboration with the Regional Clinical Compliance Head, who serves as the primary point of contact with Global Clinical Compliance (GCC). The role facilitates effective communication, alignment, and implementation of GCC strategies and initiatives within the region.