GCP QA Consultant

• Review key clinical trial documentation, including protocols, investigator brochures, informed consent forms, and trial master files
• Lead assessments and investigations of quality issues, including root cause analysis, remediation, and timely resolution
• Facilitate reviews of potential serious breaches and urgent safety measures for assigned clinical programs
• Coordinate GCP-GVP vendor audits, manage audit programs, and ensure proper execution and closure of audits
• Oversee quality management with functional lines and vendors, including leading Quality Oversight Committee meetings
• Collaborate on implementing risk-based quality management (RBQM) strategies for studies, including critical data identification and reporting
• Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis and strategy development
• Provide guidance and training on compliance issues, leveraging expertise in GCP and industry best practices
• Support the development, implementation, and maintenance of GCP standard operating procedures (SOPs)

• 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
• Excellent problem-solving skills and adaptability
• Strong communication and collaboration abilities

Familiarity with oncology clinical trials