Senior GxP CS Audit Leader | Risk, Compliance & Readiness

BeiGene, Ltd.; United States; Remote; USD 137.000 - 182.000; Vollzeit

Zusammenfassung

BeOne Medicines Ltd. seeks a Senior Manager to lead the global computerized systems audit program for GxP environments across clinical, manufacturing, and quality processes.

You will assess data integrity, cybersecurity, vendor practices, and CAPA effectiveness to ensure inspection readiness and regulatory compliance. The role requires expert technical judgment, global regulatory knowledge, and strong cross-functional collaboration with Quality, IT, Manufacturing, and Regulatory teams.

Qualifikationen

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance or related discipline.
• Advanced degree or relevant professional certification preferred.
• Minimum of 5 years of experience auditing GxP computerized systems, software vendors, cloud service providers, or IT service providers supporting regulated activities.

Aufgaben

• Develop and maintain the global computerized systems audit strategy and risk-based audit plan for GxP computerized systems.
• Prioritize audit coverage based on system criticality, data integrity risk, regulatory impact, business process dependency, and prior compliance history.
• Present audit trends, systemic risks, and compliance metrics to executive quality governance forums.
• Lead audits of software vendors, cloud service providers, SaaS platforms, hosting providers, outsourced IT service providers, and other third parties.

Kenntnisse

GxP auditing

Risk-based auditing

Regulatory compliance

Cybersecurity governance

Vendor oversight

Quality assurance

Cross-functional collaboration

Technical writing

Audit planning

Regulatory knowledge

Ausbildung

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance

Advanced degree or professional certification preferred

Tools

MS Office

Audit management platforms

eQMS

Document management systems

Jobbeschreibung

BeOne Medicines Ltd. seeks a Senior Manager to lead the global computerized systems audit program for GxP environments across clinical, manufacturing, and quality processes.

You will assess data integrity, cybersecurity, vendor practices, and CAPA effectiveness to ensure inspection readiness and regulatory compliance. The role requires expert technical judgment, global regulatory knowledge, and strong cross-functional collaboration with Quality, IT, Manufacturing, and Regulatory teams.