Regional Clinical Compliance Director

Overview

BeOne Medicines is rapidly growing and seeking an experienced Regional Clinical Compliance Director. In this role, you will implement Global Clinical Compliance and Inspection Management strategies across global, regional, country, site, and/or study levels. The position demands scientific and business acumen, collaboration, and a passionate interest in fighting cancer.

General Description

The Regional Clinical Compliance Director is responsible for providing compliance oversight and quality support to BeOne study teams. You will ensure GCP compliance, inspection readiness, and systematic adherence to regulatory requirements while identifying and addressing non-compliance and quality issues.

Essential Functions

• Lead and guide the Regional Clinical Compliance team.
• Collaborate with global and regional stakeholders to ensure timely issue identification.
• Support drafting of responses and CAPA for audit findings and inspections.
• Monitor key compliance indicators and conduct trend analysis.
• Develop and implement global GCP inspection readiness programs and training materials.

Core Competencies & Skills

Expertise in ICH/GCP regulations, clinical operations, analytical and managerial skills, and clear communication are essential. You will also be expected to mentor staff and support career development.

Qualifications

• Bachelor’s degree or higher in a scientific, medical, or healthcare discipline.
• Minimum 14 years of progressive clinical operations and GCP compliance experience.
• Experience in oncology global trials is preferred.
• Proficiency in MS Office and relevant computer skills.
• Up to 10-15% travel required.

Key skills/competency

• GCP
• Compliance
• Inspection
• Clinical Trials
• Regulatory
• Quality
• Leadership
• Risk Management
• CAPA
• Collaboration