Auditor - GCP

About the role

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.

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 systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial 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 up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.

Required Education

Bachelor's Degree in a relevant biological science, science, or related discipline.

Skills and Experience

• Academic Background: BS degree in a relevant biological science, science, or related discipline
• Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
• Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
• Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external 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
• 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 with limited supervision and manage a schedule that includes up to 50% travel.

Benefits

To learn more about CSL benefits visit How CSL Supports Your Well-being | CSL.

Contact Information

Phone: 610-878-4000