Job Title: Associate Director, Clinical Quality Assurance
Location: Cape Town, SA
Reporting to: Director of Clinical Quality Assurance
Position Summary:
IAVI is seeking a highly qualified Associate Director, Clinical Quality Assurance that will lead the compliance of Clinical Development operations within the IAVI quality policy and ensuring all applicable regulations, industry standards, and requirements are met. The successful candidate will facilitate the Clinical Development team’s participation in the IAVI quality management system where appropriate processes, procedures, and controls are established to ensure that clinical research is conducted accordingly.
Key Responsibilities:
- Support Project Teams with the development of Quality Management Plans relevant to the specific project(s).
- Prepare and assist Project Teams for regulatory inspections and external Sponsor audits.
- Act as liaison between IAVI’s 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.
- Oversee implementation of GCP CAPAs and conduct the required effectiveness checks.
- Perform other tasks as assigned by the manager.
Education and Work Experience:
- Masters or equivalent in Clinical Research and/or Public Health field is required.
- Minimum 8 years of experience in clinical research, of which at least 3 have been in Quality Assurance, is required.
- Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly desirable.
Qualifications and Skills:
- Knowledge and understanding of industry standards and research operations as pertinent to vaccine development is required.
- Experience working with electronic data and records in CFR21Part11 compliant environments is required.
- Knowledge and understanding of quality management systems is required.
- Self-motivation, detail-orientation, and ability to handle significant responsibility as well as shift priorities, exercising discretion, and taking initiative to resolve problems is required.
- Ability to work well with all levels of staff both within an organization, across functions, and across cultures with demonstrated ability to work effectively in cultures and environments other than one’s own is required.
- Excellent written, verbal, and presentations skills are required.
- Experience as auditor of public health trials is highly desirable.
- Experience working in remote-, virtual-, global-, teams, is highly desirable.
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 actively committed to fostering a diverse and inclusive global organization. IAVI believes that diversity and inclusion among our teammates is critical, and we seek to recruit, develop and retain the most talented people from a representative candidate pool. 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 global non-profit. IAVI upholds these principles through IAVI’s Global Diversity and Inclusion Committee.
IAVI has zero tolerance for discrimination or harassment on the basis of race, color, ethnicity, caste, national origin, home language, ancestry, religion, marital or civil partnership status, age, physical or mental disability, HIV status and any other medical condition, genetic information, pregnancy, sexual orientation, gender identity or expression, and veteran status, in addition to any other status protected under the law in any of our locations worldwide.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)