Director, Human Subject Research Quality at International AIDS Vaccine Initiative (IAVI)

Position Summary:

IAVI is seeking a Director, Human Subject Research Quality, to lead HSR Quality Assurance, and oversee the development, implementation, and monitoring of global quality standards for HSR operations. This experienced Quality leader will lead HSR quality which includes Clinical studies (GCP & GCLP), epidemiological, as well as socio-behavioral research. The Director will be integral in driving quality oversight, implementing risk management strategies, and developing robust procedures for quality assurance in human subject research. If you're a seasoned professional with extensive experience in quality assurance and public health research, eager to make an impact in a mission-driven organization, apply now!

Key Responsibilities:

• Develop and maintain a database of quality standards for HSR operations.
• Develop and implement Quality Oversight Plans for HSR in line with QA objectives and industry standards.
• Track and monitor the progress of implementing Quality Oversight Plans.
• Report to the Senior Director on the execution of Quality Oversight Plans as per unit reporting requirements.
• Develop procedures to support quality oversight of HSR operations.
• Act as the point person for integration and alignment of HSR-related documents with IAVI’s guidance and procedures.
• Develop a training plan for HSR QA staff.
• Develop an annual internal audit plan.
• Review unit and project risk registers and develop/maintain an HSR Risk Register.
• Support the preparation of HSR sites for regulatory inspections and sponsor assessments.
• Oversee the work of Associate Directors for GCP and GCLP Quality Assurance and manage their teams.
• Facilitate the development of quality management systems and tools for HSR operations.
• Serve as the HSR QA representative on project teams.
• Perform other QA duties as assigned by the Senior Director of Quality Assurance.

Education and Work Experience:

• Master's degree in Public Health or a related field is required.
• Minimum of 10 years of experience in managing public health Human Subject Research, with a minimum of 5 years in Quality Assurance is required.
• Extensive experience with global research operations and supporting global studies in an NGO environment is highly preferred.
• Strong background in risk management within a HSR environment.