Global Regulatory Compliance Lead — Audit Readiness & Risk

BeOne Medicines

United States

On-site

USD 140,000 - 185,000

Full time

14 days+

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Benefits offered by this job

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

Job summary

BeOne Medicines in the United States is seeking a Senior Manager, Global Regulatory Compliance & Inspection Readiness to lead regulatory compliance programs, strengthen inspection readiness, and manage regulatory information systems.

The role partners across Global Regulatory Affairs, Quality, Clinical, and other functions to ensure processes remain compliant, oversee audits, monitor data quality in Veeva RIM, and drive continuous improvement with remediation actions. Travel <15%.

Qualifications

  • Bachelor's degree in Life Sciences or related field; advanced degree preferred.
  • 7+ years in regulatory affairs, compliance, or a GxP function.
  • Experience leading audits/inspections and readiness activities.
  • Strong data management and KPI experience.

Responsibilities

  • Lead GRA compliance programs and risk assessments.
  • Coordinate audits and health authority inspections readiness.
  • Manage regulatory information quality and data stewardship.
  • Develop and monitor KPIs and dashboards.

Skills

Regulatory leadership
Risk assessment
Cross-functional collaboration
Data analytics
Audits & inspections

Education

Bachelor's degree in Life Sciences or related field; advanced degree preferred

Tools

Veeva Vault RIM
Power BI
Tableau

Job description

BeOne Medicines in the United States is seeking a Senior Manager, Global Regulatory Compliance & Inspection Readiness to lead regulatory compliance programs, strengthen inspection readiness, and manage regulatory information systems.

The role partners across Global Regulatory Affairs, Quality, Clinical, and other functions to ensure processes remain compliant, oversee audits, monitor data quality in Veeva RIM, and drive continuous improvement with remediation actions. Travel <15%.

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