BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description
The Regional Clinical Compliance (RCC) Inspection Manager 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 integral 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.
Essential Functions Of Job
Inspection readiness implementation and oversight
- Organize briefing materials, logistics, and stakeholder alignment
- Support inspection readiness across the EMEA region
- Support implementation of standards, tools, and best practices
- Ensure teams are inspection-ready through training and guidance
- Assess inspection risks and oversee mitigation plans
- Supports mock inspections and readiness assessments
- Maintain inspection-ready documentation, processes, and systems
- Supports development of story boards based on global story boards templates and structure and acting as subject matter expert (SME) in content generation together with the relevant functional area SMEs
Inspection and Audit Preparation, Execution and Follow up
- Support regional preparation activities for