Global Clinical Operations Leader & Compliance Strategy

BeOne Medicines Ltd.; San Mateo (CA); On-site; USD 230,000 - 350,000; Full time

Job summary

BeOne Medicines Ltd. seeks an executive to join the GCO Leadership team, shaping Clinical Development & GCO strategies and leading quality, compliance, and operations excellence across trials conducted by GCO and partners.

You will build and lead a high-capability team, drive a proactive GCP compliance program including eTMF management, SOPs, and training, and ensure adherence to ICH/FDA/EMA guidelines with KPIs to measure performance.

Qualifications

• BS, with advanced degrees preferred, in a scientific or healthcare discipline.
• At least 15 years in biotech/pharma/CRO in Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance.
• Fluent in written and verbal English; Mandarin knowledge is desirable.

Responsibilities

• Lead end-to-end GCP quality systems and SOP development across Global Clinical Operations.
• Identify root causes for major observations and drive CAPA and preventive actions.
• Direct and mentor multi-national, cross-functional teams to ensure regulatory compliance.
• Travel up to 25% as required by project needs.

Skills

GCP quality systems

Project management

Leadership

Root cause analysis

Quality assurance

Education

BS in scientific/healthcare discipline

Advanced degree preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

PowerPoint

Outlook

Job description

BeOne Medicines Ltd. seeks an executive to join the GCO Leadership team, shaping Clinical Development & GCO strategies and leading quality, compliance, and operations excellence across trials conducted by GCO and partners.

You will build and lead a high-capability team, drive a proactive GCP compliance program including eTMF management, SOPs, and training, and ensure adherence to ICH/FDA/EMA guidelines with KPIs to measure performance.