Global R&D Audit & Inspection Readiness Lead

BeOne Medicines Ltd.; United States; On-site; USD 148,000 - 193,000; Full time

Job summary

BeOne Medicines Ltd. in the United States seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive continuous regulatory compliance across R&D technology solutions.

You translate audit readiness strategy into practical day-to-day actions within Agile delivery, CSV/CSA, and data integrity requirements. You will lead internal and external readiness activities, coach SMEs and vendors, and ensure evidence packages, test artifacts, and documentation meet GxP expectations and

Qualifications

• Bachelor's degree in a related field is required; advanced degree is a plus.
• 7+ years in IT compliance, QA, software engineering, validation, or audit readiness.
• 3+ years supporting audit/inspection readiness activities and vendor audits.

Responsibilities

• Lead internal audits, mock inspections, and inspection readiness exercises.
• Coordinate validation artifacts, evidence packages, and traceability matrices for assigned systems.
• Coach SMEs and vendors on audit protocols and regulatory communication.
• Oversee CSV/CSA execution for vendor-hosted or external systems.

Skills

GxP compliance

Audit readiness

CSV/CSA

Regulatory knowledge

Agile/Scrum

Documentation excellence

Vendor management

Education

Bachelor's degree in related field

Job description

BeOne Medicines Ltd. in the United States seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive continuous regulatory compliance across R&D technology solutions.

You translate audit readiness strategy into practical day-to-day actions within Agile delivery, CSV/CSA, and data integrity requirements. You will lead internal and external readiness activities, coach SMEs and vendors, and ensure evidence packages, test artifacts, and documentation meet GxP expectations and