Global GCP Auditor | Data Integrity & CAPA

CSL Vifor; Waltham (MA); On-site; USD 100,000 - 140,000; Full time

Job summary

CSL Vifor is seeking a GCP Auditor to join the R&D Quality audit program, executing the global audit plan to ensure data integrity and compliance with legal and corporate standards. You will audit clinical investigator sites, CROs, and internal trial management processes.

The role requires 3+ years QA in a GCP-regulated environment, strong communication, and travel up to 50%. You will report findings and CAPA, support SOP improvements, and stay current with ICH GCP and related regulations.

Qualifications

• BS degree in a relevant biological science, science, or related discipline.
• 3+ years of Quality Assurance experience within a GCP-regulated environment, with knowledge of clinical trial phases, monitoring, and regulatory frameworks.
• Experience in clinical audit and inspection management.
• Excellent interpersonal and negotiation skills for multinational teams, investigators, and external CROs.
• Working knowledge of ICH E6 (R3) and main CFR/CTR directives.

Responsibilities

• Audit external audits of clinical investigator sites, CROs, E-System providers, and IRBs/ECs.
• Develop and issue Audit Reports, categorizing findings by risk level and providing CAPA recommendations.
• Identify non-compliance trends and systematic risks, communicating findings to management and leads.
• Support SOP improvements and partner with stakeholders to develop risk-based, compliant solutions.
• Maintain up-to-date knowledge of global GCP regulations and industry trends.

Skills

Audit execution

Reporting & CAPA

Trend analysis

Regulatory knowledge

Communication skills

Analytical ability

Education

BS degree in biological sciences or related discipline

Tools

ICH E6 (R3)

21 CFR Part 11

21 CFR Part 50

21 CFR Part 312

21 CFR Part 812

CTR EU 536/2014

GCP Directive

Clinical Trials Directive

Job description

CSL Vifor is seeking a GCP Auditor to join the R&D Quality audit program, executing the global audit plan to ensure data integrity and compliance with legal and corporate standards. You will audit clinical investigator sites, CROs, and internal trial management processes.

The role requires 3+ years QA in a GCP-regulated environment, strong communication, and travel up to 50%. You will report findings and CAPA, support SOP improvements, and stay current with ICH GCP and related regulations.