Global GVP QA Lead, R&D Quality & Compliance

BeOne Medicines Ltd.; California; On-site; USD 150,000 - 230,000; Full time

Job summary

BeOne Medicines Ltd. seeks a GVP Quality Lead to implement and maintain a proactive global PV QA framework supporting an oncology pipeline. You will influence senior leadership and ensure PV activities meet regulatory standards across development stages.

The role emphasizes QA system development, vendor oversight, risk management, and inspection readiness, with travel as needed. A strong background in GVP/GCP and global regulations is essential.

Qualifications

• Bachelor degree and 8+ years of Pharmacovigilance experience.
• Master's degree and 6+ years of related experience preferred.
• Expert global knowledge of GVPs and GCP requirements.
• Understanding of international regulations for clinical trials and pharmacovigilance operations.
• Ability to lead in a matrixed global organization and drive improvements.
• Promote continuous improvements in quality systems and department infrastructure.

Responsibilities

• Audit & Inspection Leadership for PV QA activities and inspections.
• Lead PV inspection readiness activities and support regulatory inspections.
• Develop and manageQuality Systems and risk management processes.
• Oversee vendor management and subcontractor QA activities.
• Develop quality KPIs and metrics and drive continuous improvement.
• Coordinate GCP/GVP training and knowledge sharing.
• Collaborate with Global Patient Safety, Regulatory Affairs, Medical, and Clinical operations to ensure PV requirements are met.

Skills

Leadership

Attention to detail

Multitasking

Cross-functional collaboration

Education

Bachelor of Science

Master's degree

Tools

Veeva

SumTotal

Smartsheet

ACE Audit Utopia

Job description

BeOne Medicines Ltd. seeks a GVP Quality Lead to implement and maintain a proactive global PV QA framework supporting an oncology pipeline. You will influence senior leadership and ensure PV activities meet regulatory standards across development stages.

The role emphasizes QA system development, vendor oversight, risk management, and inspection readiness, with travel as needed. A strong background in GVP/GCP and global regulations is essential.