Global Senior GxP CS Audit Leader

BeiGene; United States; Remote; USD 137,000 - 182,000; Full time

Benefits offered by this job

Competitive salary

Bonus plan

Excellent benefits

Job summary

BeOne Medicines Ltd. seeks a Senior Manager, GxP Computerized Systems Auditing to lead the global risk-based audit program for GxP computerized systems across clinical, manufacturing, and quality domains.

You will partner with Quality, IT, and regulatory teams to assess risks, drive CAPAs, and support inspections, while advancing audit methodology and vendor oversight in a fast-paced, international setting.

Qualifications

• Bachelor's degree in a related field; advanced degree or certification preferred.
• Strong knowledge of GxP compliance, 21 CFR Part 11, EU Annex 11/15, ISPE GAMP.
• Experience auditing GxP systems and vendors across global operations.

Responsibilities

• Develop and maintain the global GxP computerized systems audit strategy and risk-based plan.
• Lead internal, supplier, and third-party audits of software and cloud providers.
• Evaluate vendor practices across development, testing, validation, change control, and cybersecurity.
• Assess data integrity, access controls, validation, and SDLC for regulated systems.
• Escalate risks and drive CAPA implementation and inspection readiness.
• Provide governance and continuous improvement for the audit program.

Skills

GxP auditing

Regulatory knowledge

Risk-based auditing

Cross-functional collaboration

Education

Bachelor's degree in life sciences/engineering/related

Tools

Audit management software

Data integrity tools

Job description

BeOne Medicines Ltd. seeks a Senior Manager, GxP Computerized Systems Auditing to lead the global risk-based audit program for GxP computerized systems across clinical, manufacturing, and quality domains.

You will partner with Quality, IT, and regulatory teams to assess risks, drive CAPAs, and support inspections, while advancing audit methodology and vendor oversight in a fast-paced, international setting.