Senior Global PV QA Lead, R&D Quality

BeOne Medicines Ltd.; Emeryville (CA); On-site; USD 140,000 - 210,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a GVP Quality Lead to support the Director, GVP Quality, in implementing a proactive, global QA framework for PV activities in a growing oncology portfolio.

This role focuses on inspection readiness and regulatory success, with exposure to senior leadership and cross-functional teams across global operations. The position emphasizes leading audits, developing quality systems, managing risk, and driving continuous improvement in GVP compliance and PV operations.

Qualifications

• 8+ years of Pharmacovigilance experience required
• GVP and GCP knowledge expected
• Understanding of international regulatory requirements for PV
• Ability to lead in a matrixed global organization
• Experience with audits, CAPAs and vendor oversight

Responsibilities

• Lead PV QA activities across all development phases
• Coordinate PV inspection readiness and regulatory inspections
• Develop and manage quality systems and risk management programs
• Oversee audits of vendors, partners, and processes
• Maintain QA KPIs and drive continuous improvement
• Provide cross-functional PV training and guidance

Skills

Audit & Inspection Leadership

Quality Systems & Risk Management

Vendor Oversight

Cross-functional Leadership

Regulatory Knowledge

Education

Bachelor of Science degree in a related field

Master’s degree preferred

Tools

Microsoft 365

Veeva

SumTotal

ACE Audit utopia

Smartsheet

Job description

BeOne Medicines Ltd. is seeking a GVP Quality Lead to support the Director, GVP Quality, in implementing a proactive, global QA framework for PV activities in a growing oncology portfolio.

This role focuses on inspection readiness and regulatory success, with exposure to senior leadership and cross-functional teams across global operations. The position emphasizes leading audits, developing quality systems, managing risk, and driving continuous improvement in GVP compliance and PV operations.