What are the responsibilities and job description for the Auditor - GCP position at CSL?
The Opportunity
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.