Global R&D Audit & Inspection Readiness Lead

BeiGene, Ltd.; United States; Remote; USD 148,000 - 193,000; Full time

Job summary

BeOne seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive regulatory compliance across R&D IT systems and SaaS solutions. You will coordinate validation artifacts, support audit readiness, and partner with Quality, Compliance, Security, and Enterprise IT to embed GxP into Agile delivery and CI/CD practices.

The role emphasizes risk-based validation, demonstration of data integrity, and effective cross-functional collaboration to support regulatory inspections globally.

Responsibilities

• Execute validation-by-design activities with software engineering, product owners, and QA to embed GxP expectations into Agile / Scrum delivery practices.
• Coordinate creation, review, and maintenance of validation deliverables (URS, FS, risk assessments, test evidence, traceability matrices, release readiness).
• Support DevOps and engineering teams in aligning automated testing, CI/CD evidence, electronic records, and release controls with audit-ready verification expectations.
• Apply delta-based validation for iterative feature updates, ensuring changes are evaluated, tested, and released per risk-based standards.
• Define and apply GxP Definition of Done criteria to ensure software completion includes required specs, evidence, controls, and compliance checkpoints.

Job description

BeOne seeks a Senior Manager, Global R&D Audits & Inspections Readiness to drive regulatory compliance across R&D IT systems and SaaS solutions. You will coordinate validation artifacts, support audit readiness, and partner with Quality, Compliance, Security, and Enterprise IT to embed GxP into Agile delivery and CI/CD practices.

The role emphasizes risk-based validation, demonstration of data integrity, and effective cross-functional collaboration to support regulatory inspections globally.