Director, GCP Quality

IAVI; Cape Town; On-site; ZAR 800,000 - 1,200,000; Full time

Job summary

A global health organization in Cape Town is seeking an experienced Director for Human Subject Research Quality to lead quality assurance efforts and implement standards for HSR operations. Ideal candidates will have over 10 years of public health experience, including at least 5 years in quality assurance, and strong leadership skills. This role involves oversight of quality management systems and requires regular travel for audits and inspections.

Qualifications

• 10+ years managing Human Subject Research in public health.
• 5+ years in Quality Assurance.
• Experience in global research operations.

Responsibilities

• Develop and maintain a database of quality standards.
• Implement Quality Oversight Plans for HSR operations.
• Oversee quality audits and inspections.

Skills

Leadership skills

Process development

Quality management systems knowledge

Risk management proficiency

Communication skills

Education

Master's degree in Public Health or related field

Job description

Overview

Job title : Director, GCP Quality

Job Location : Western Cape, Cape Town

Deadline : October 10, 2025

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 Human Subject Research 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.

Qualifications and Skills

• Strong leadership skills with a cooperative approach.
• Expertise in process development and procedure platform creation.
• In-depth knowledge of quality management systems and their requirements.
• Proficient in risk management systems and problem-solving.
• Ability to work in a remote and virtual team environment.
• Outstanding communication skills with experience working in multicultural teams.
• Familiarity with therapeutic areas relevant to IAVI’s mission.
• Mobility to perform essential functions of the position.
• Ability to work in a virtual team.
• Ability to communicate clearly in person and via telephone.
• Regular travel (up to 40%) for audits, meetings, and inspections as needed, including travel to IAVI offices in New York and international sites.
• Administrative / Management jobs