GCP QA Consultant

Job Summary

A company is looking for a GCP QA Consultant to support clinical programs and trials with a focus on Good Clinical Practice compliance.

Key Responsibilities:

• Review key clinical trial documentation, including protocols and informed consent forms
• Lead assessments and investigations of quality issues, including root cause analysis and remediation
• Coordinate GCP-GVP vendor audits and oversee quality management with functional lines and vendors

Required Qualifications and Education:

• Strong background in clinical quality assurance and GCP compliance
• Experience in reviewing and managing clinical trial documentation
• Knowledge of regulatory inspection processes and risk-based quality management
• Ability to lead audits and manage CAPAs effectively
• Familiarity with oncology clinical trials is preferred