GCP Audit Lead — Clinical Trials & Compliance

CSL Plasma; Waltham (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

CSL Plasma is seeking a GCP Auditor in our Quality Assurance program in Waltham, MA. The role will execute external audits of investigator sites, CROs, and IRBs/ECs to ensure data integrity and regulatory compliance.

The successful candidate will identify non-compliance trends, prepare comprehensive audit reports, and recommend CAPAs. You will help improve SOPs and work with stakeholders to implement risk-based, compliant solutions across global clinical development programs.

Qualifications

• 3+ years of Quality Assurance experience within a GCP-regulated environment.
• Experience in clinical audit and inspection management.
• Excellent interpersonal and negotiation skills.

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 provide CAPA recommendations.
• Trend Analysis: Identify non-compliance trends and systemic risks within GCP.
• Continuous Improvement: Help update SOPs and partner with stakeholders for compliant solutions.
• Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations and trends.

Education

BS degree in biological science

Job description

CSL Plasma is seeking a GCP Auditor in our Quality Assurance program in Waltham, MA. The role will execute external audits of investigator sites, CROs, and IRBs/ECs to ensure data integrity and regulatory compliance.

The successful candidate will identify non-compliance trends, prepare comprehensive audit reports, and recommend CAPAs. You will help improve SOPs and work with stakeholders to implement risk-based, compliant solutions across global clinical development programs.