Director, GCP Quality

Position Description

Job Title: Director, Human Subject Research Quality
Location: Cape Town, South Africa, Remote-South Africa, Nairobi, Kenya, Remote- Uganda, Remote-Nigeria, 
Reporting to:  Senior Director, Human Subject Research Quality Assurance

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.

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 VALUES:

• Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions
• Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up 
• Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect 
• Collaboration: We are committed to embracing diversity, the power of global teamwork and the belief that by working as one we can make a difference

Disclaimer: Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities and skills required of personnel so classified. This document does not create an employment contract, implied or otherwise, other than an "at-will" relationship. 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 AN EQUAL OPPORTUNITY EMPLOYER dedicated to fostering a diverse and inclusive global organization. We recognize that a variety of backgrounds and perspectives enriches our work and strengthens our ability to achieve our mission. IAVI is committed to recruiting, developing, and retaining individuals through a merit-based approach. 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.

Zero Tolerance

IAVI is an equal opportunity employer. It is IAVI's policy to provide equal opportunity without regard to race, citizenship, color, sex, gender identity or expression, age, height, weight, disability (including physical and mental conditions unrelated to job performance), religion, creed, caste, home language, ancestry, national origin, pregnancy, marital or partnership status, sexual orientation, status as a protected veteran, ethnicity, genetic information, predisposing genetic characteristic, status as a victim of domestic violence, stalking and sex offenses, HIV status, or any other status protected by applicable federal, state, or local laws.

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.