Senior Manager, GxP CS Auditing

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

Benefits dieser Stelle

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Zusammenfassung

BeOne Medicines Ltd. seeks a Senior Manager, GxP Computerized Systems Auditing to lead a risk-based audit program for CMS in GxP environments.

You will oversee audits across validation, change control, data integrity, cybersecurity, vendor oversight, and ELS compliance, partnering with Quality, IT, Manufacturing, Regulatory, and third parties. Responsibilities include developing the global audit strategy, prioritizing coverage by risk, presenting trends to governance forums, and driving CAPA

Qualifikationen

• Bachelor’s degree in a related field; 7+ years of CMS audit experience.
• Strong regulatory knowledge of GxP and global GMP/GDP requirements.
• Experience leading internal, supplier, and third‑party audits.
• Excellent technical writing, communication, and stakeholder management.
• Willingness to travel 30–50%.

Aufgaben

• Develop and execute risk-based global CMS audit strategy.
• Lead audits of internal and external service providers.
• Present audit findings and risk metrics to governance forums.
• Ensure CAPA adequacy and timely closure.
• Support inspection readiness and health authority inspections.

Kenntnisse

GxP CMS audits

Regulatory knowledge

Cross-functional collaboration

Audit planning and leadership

Ausbildung

Bachelor's degree in Computer Science/Information Systems/Engineering/Life Sciences/Quality Assurance

Advanced degree or relevant professional certification

Tools

Audit management platforms

MS Office Suite

Jobbeschreibung

BeOne Medicines Ltd. seeks a Senior Manager, GxP Computerized Systems Auditing to lead a risk-based audit program for CMS in GxP environments.

You will oversee audits across validation, change control, data integrity, cybersecurity, vendor oversight, and ELS compliance, partnering with Quality, IT, Manufacturing, Regulatory, and third parties. Responsibilities include developing the global audit strategy, prioritizing coverage by risk, presenting trends to governance forums, and driving CAPA