Auditor - GCP

CSL Vifor; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Job summary

CSL Vifor is seeking a GCP Auditor to join our R&D Quality audit program. You will execute the global audit plan, assess trial integrity, and drive corrective actions with stakeholders across clinical operations.

The role requires 3+ years in QA within a GCP-regulated environment, strong knowledge of ICH E6 and CFRs, and the ability to travel up to 50% to sites and vendors worldwide.

Qualifications

• BS degree in a relevant biological science or related discipline.
• 3+ years of Quality Assurance experience within a GCP-regulated environment.
• Experience in clinical audit and inspection management.
• Excellent communication with multinational teams.
• In-depth knowledge of ICH E6 (R3) and FDA CFR parts.

Responsibilities

• Audit execution: conduct external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs.
• Reporting & risk categorization: develop audit reports and categorize findings with CAPA recommendations.
• Trend analysis: identify non-compliance trends and systemic risks across the GCP discipline.
• Continuous improvement: support SOP improvements and risk-based, compliant mitigation strategies.
• Regulatory knowledge: stay current with global GCP regulations to ensure trial quality.

Skills

Quality Assurance

GCP Knowledge

Audit Management

Communication

Travel Ready

Education

BS in Life Sciences

Job description

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 our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. Seeking an experienced auditor who can navigate complex clinical environments and work collaboratively 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 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.

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

  • Clinical Trials Regulation (CTR) (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 with limited supervision and manage a schedule that includes up to 50% travel.