Senior GxP CS Audit Leader Strategy & Compliance

BeOne Medicines; United States; On-site; USD 137,000 - 182,000; Full time

Job summary

BeOne Medicines seeks a Senior Manager, GxP Computerized Systems Auditing, to lead a risk-based audit program for GxP systems across clinical, manufacturing, and quality domains. You will work with Quality, IT, Regulatory, and external partners to assess risks, identify control gaps, and drive corrective actions.

The role encompasses audit strategy, vendor and third-party audits, IT controls, data integrity, cybersecurity, and support for inspections.

Qualifications

• Bachelor’s degree in a relevant field; 7+ years of computerized systems audit experience required OR Master’s degree with 5+ years of experience.
• Strong working knowledge of GxP computerized systems including 21 CFR Part 11 and ISPE GAMP guidance.
• Experience auditing GxP systems, software vendors, cloud providers, or IT service providers.
• Excellent technical writing, interviewing, communication, and stakeholder management skills.

Responsibilities

• Develop and maintain the global GxP audit strategy and risk-based plan.
• Present audit trends and compliance metrics to executive governance forums.
• Lead internal, supplier, vendor, and third-party audits of computerized systems.
• Evaluate vendor development, validation, cybersecurity, and service management practices.
• Assess third-party compliance and CAPA adequacy.
• Support GxP inspections and audit readiness.

Skills

MS Office

Auditing

Regulatory knowledge

Analytical thinking

Stakeholder management

Education

Bachelor’s degree in CS/IS/Engineering/Life Sciences/QA

Advanced degree or professional certification preferred

Tools

Audit management platform

eQMS

Document management system

Audit reporting tools

Job description

BeOne Medicines seeks a Senior Manager, GxP Computerized Systems Auditing, to lead a risk-based audit program for GxP systems across clinical, manufacturing, and quality domains. You will work with Quality, IT, Regulatory, and external partners to assess risks, identify control gaps, and drive corrective actions.

The role encompasses audit strategy, vendor and third-party audits, IT controls, data integrity, cybersecurity, and support for inspections.