Associate Director, Global Quality Assurance

Associate Director, Global Quality Assurance

IAVI Cape Town, Western Cape, South Africa

Location : Nairobi, Kenya, Cape Town, South Africa; Remote-South Africa, Remote-Uganda, Remote-Nigeria, New York, New York; US - Remote Considered; United Kingdom – Remote; OR Amsterdam, Netherlands

Reporting to : Senior Director, Clinical Quality Assurance

Position Summary

Are you a Quality focused leader in clinical development, passionate about bringing forward public health solutions? IAVI is seeking an experienced and detail oriented Associate Director, Quality Assurance who will ensure compliance of clinical development operations to IAVI and industry standards. The Associate Director will facilitate the Clinical Development group’s participation in the IAVI management system where appropriate processes, procedures, and controls are established to ensure clinical research is conducted according to IAVI and industry standards

Key Responsibilities

• Support Project Teams with the development of management plans relevant to the specific project(s);
• Support and prepare Project Teams for regulatory inspections and external Sponsor audits;
• Serves as the GCP point person for the IAVI electronic QMS, and Clinical Trial Systems, development and implementation;
• Develop and implement QMS compliance assessments for the GCP component of the QMS;
• Develop and implement an eTMF inspection readiness assessment plan for all IND studies;
• Participate in executing the audit plan as delegated;
• Provide training to GCP Operations on best practices and trends as indicated;
• Oversees implementation of GCP CAPAs and conduct the required effectiveness checks;
• Perform other tasks as assigned by the manager.

Education and Work Experience

Qualifications and Skills

Organizational Overview

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis. Our mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Through scientific and clinical research in Africa, India, Europe, and the U.S., IAVI is pioneering the development of biomedical innovations designed for broad global access. We develop vaccines and antibodies in and for the developing world and seek to accelerate their introduction in low-income countries. IAVI programs and partnerships are grounded in the regions of the world where the disease burden is the greatest, and our approach emphasizes sustainability. Our network of clinical research center partners in Africa and India helps strengthen in-country research capacity and supports the training and education of the next generation of scientists. The global impact of our science includes fundamental contributions to understanding the biology of HIV infection, which IAVI and others are applying toward advancing vaccine science and immunology. IAVI accelerates scientific discovery and development by fostering unique collaborations among academia, industry, local communities, governments, and funders to explore new and better ways to address public health threats that disproportionately affect people living in poverty. Our global reach, including a clinical research network in five countries in sub-Saharan Africa and in India, has allowed us to make fundamental contributions to understanding the epidemiology, transmission, virology, and immunology of HIV. This work played a key role in facilitating the design of promising HIV vaccine candidates, as well as the discovery of broadly neutralizing antibodies that are now being advanced as promising approaches for HIV prevention. Our integrated capabilities in vaccine and antibody discovery, development, and clinical research take advantage of bio-pharmaceutical industry expertise to accelerate the development and testing of prevention methods for HIV and other diseases. Through the Product Development Center, we support external researchers with technical and scientific expertise to accelerate the development of their own products.

IAVI CORE

Compensation And Benefits Information

Salary is paid in local currency, and is commensurate and competitive with the local labor market. Please note, there may be some variation based on experience level. In addition, this position offers competitive benefits such as annual bonus, generous retirement savings plan, competitive health insurance benefits, and other benefits.

Seniority level

Employment type

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Equal Opportunity Employer

IAVI is an equal opportunity employer and applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. IAVI is a non-profit scientific research organization dedicated to addressing global health challenges and is committed to fostering a diverse and inclusive global organization. At IAVI, we celebrate the spectrum of colleagues’ experiences and believe that dedication to our mission above all is essential to our success as a scientific non-profit organization focused on global health.

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