Executive Director, Global Clinical Operations & Compliance

BeiGene, Ltd.; United States; Remote; USD 272,000 - 352,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a senior leader to drive GCO quality, compliance, and operational excellence across global clinical trials. You will build and oversee eTMF, SOPs, CAPA programs, and training, aligning with ICH, FDA, EMA standards.

This role leads cross-functional teams and vendor relations to ensure inspections readiness and compliant trial execution. The position requires extensive experience in clinical operations, quality assurance, and process improvement, with strong

Qualifications

• BS with advanced degrees preferred.
• 15+ years in biotech/pharma/CRO in Clinical Operations, Clinical Compliance, or Clinical Quality Assurance.

Responsibilities

• Lead end-to-end clinical trial oversight and SOP development and revision.
• Develop training plans and ensure training compliance across GCO.
• Establish and report KPIs/KQIs and drive continuous improvement across global trials.

Skills

GCP quality systems

Leadership

Quality assurance

Process improvement

Cross-functional collaboration

Education

BS in scientific/healthcare field

Tools

Microsoft Word

Excel

Project

PowerPoint

Outlook

Job description

BeOne Medicines Ltd. is seeking a senior leader to drive GCO quality, compliance, and operational excellence across global clinical trials. You will build and oversee eTMF, SOPs, CAPA programs, and training, aligning with ICH, FDA, EMA standards.

This role leads cross-functional teams and vendor relations to ensure inspections readiness and compliant trial execution. The position requires extensive experience in clinical operations, quality assurance, and process improvement, with strong