Auditor - GCP

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

This role serves as a GCP Auditor within our Research & Development Quality Audit Program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards.

By conducting audits of clinical investigator sites, external vendors, and internal trial management processes, you will identify findings and non-compliance trends that could impact the integrity of clinical research. We are seeking an experienced auditor who can navigate complex clinical environments and collaborate with stakeholders to develop corrective actions that ensure long-term systemic stability.

The Role

• Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs).
• Reporting & Risk Categorization: Develop and issue comprehensive audit reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
• Trend Analysis: Identify non-compliance trends and systemic risks within the GCP discipline. Communicate findings to management and clinical functional leads to strengthen trial quality and robustness.
• Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
• Regulatory Knowledge: Maintain current knowledge of global GCP regulations, including ICH E6, and emerging industry trends to ensure quality across clinical development programs.

Skills & Experience

• Education: Bachelor's degree in Biological Sciences, Life Sciences, or a related discipline.
• Quality Assurance Experience: 3+ years of Quality Assurance experience in a GCP-regulated environment with a strong understanding of clinical trial phases, monitoring activities, and regulatory requirements.
• Audit Expertise: Experience in clinical audit and inspection management with a strong understanding of quality assurance requirements within clinical research.
• Communication Skills: Excellent interpersonal, relationship-building, and negotiation skills with the ability to work effectively across multinational clinical teams, investigators, and CROs.

Working Knowledge Of:

• ICH E6 (R3) Guideline
• 21 CFR Part 11: Electronic Records; Electronic Signatures
• 21 CFR Part 50: Protection of Human Subjects (Informed Consent)
• 21 CFR Part 312: Investigational New Drug Application
• 21 CFR Part 812: Investigational Device Exemptions
• Clinical Trials Regulation (EU) No. 536/2014
• Directive 2001/20/EC (Clinical Trial Directive)
• Directive 2005/28/EC (GCP Directive)
• Directive 2001/83/EC (Annex I)

Organizational Agility:

Strong analytical and problem-solving skills with the ability to work independently and manage a schedule that includes up to 50% travel.