Global GCP Auditor: Data Integrity & Compliance

CSL; Kankakee (IL); On-site; USD 90,000 - 135,000; Full time

Job summary

CSL is seeking a GCP Auditor to execute the global audit plan and ensure data integrity across clinical trials. The role involves auditing investigator sites, CROs, and trial management processes to identify findings and non-compliance trends.

You will develop corrective actions, support SOP improvements, and collaborate with stakeholders to sustain long-term systemic quality in a dynamic clinical development environment. Travel up to 50% is required.

Qualifications

• 3+ years of Quality Assurance experience in a GCP-regulated environment.
• Experience auditing clinical investigator sites, CROs, and trial management processes.
• Strong understanding of clinical trial phases and regulatory requirements.
• Excellent interpersonal and negotiation skills for multinational teams.

Responsibilities

• Audit Execution: Conduct external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs.
• Reporting & Risk Categorization: Develop audit reports, categorize findings by risk, and propose CAPA.
• Trend Analysis: Identify non-compliance trends and systemic risks; communicate with management.
• Continuous Improvement: Support SOP improvements and risk-based, compliant solutions for trial management.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations and trends.

Skills

Quality Assurance

Audit

GCP

Communication

Education

Bachelor's degree in Biological Sciences

Job description

CSL is seeking a GCP Auditor to execute the global audit plan and ensure data integrity across clinical trials. The role involves auditing investigator sites, CROs, and trial management processes to identify findings and non-compliance trends.

You will develop corrective actions, support SOP improvements, and collaborate with stakeholders to sustain long-term systemic quality in a dynamic clinical development environment. Travel up to 50% is required.