Senior GxP Computerized Systems Audit Lead (Remote)

BeiGene, Ltd.; Northern (KY); Hybrid; USD 137,000 - 182,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

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

You will oversee audits of validation, change control, data integrity, cybersecurity, and vendor oversight to ensure inspection readiness and strong CAPA execution. The role requires deep regulatory knowledge (21 CFR Part 11, EU Annex 11/15, ISPE GAMP), excellent writing and communication skills, and

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline.
• 7+ years of computerized systems audit experience (or 5+ with Master’s degree).
• Advanced degree or relevant professional certification preferred.
• Strong knowledge of GxP regulatory requirements (21 CFR Part 11, EU Annex 11/15, ISPE GAMP).

Responsibilities

• Develop and maintain the global computerized systems audit strategy and risk-based audit plan for GxP systems.
• Lead internal, supplier, contract, and partner audits of computerized systems.
• Evaluate vendor development, validation, cybersecurity, and service management.
• Escalate systemic risks and support inspection readiness and CAPA evaluation.
• Serve as process owner for the global computerized systems audit program.

Skills

GxP knowledge

Auditing experience

Regulatory knowledge

Stakeholder management

Education

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality Assurance, or related discipline

Advanced degree or relevant professional certification

Tools

Audit management platforms

Job description

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

You will oversee audits of validation, change control, data integrity, cybersecurity, and vendor oversight to ensure inspection readiness and strong CAPA execution. The role requires deep regulatory knowledge (21 CFR Part 11, EU Annex 11/15, ISPE GAMP), excellent writing and communication skills, and