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.
Job Description
- Support Project Teams with the development of quality 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:
- Masters Degree or equivalent in Clinical Research and/or Public Health or related field is required.
- Minimum 10 years of experience in clinical research is required of which at least 3 in Quality Assurance is required.
- Certification as GCP Auditor and/or Post Graduate Qualification in Quality Management is highly preferred.
Method of Application
Meet the Qualifications? Apply now at International AIDS Vaccine Initiative (IAVI) on recruiting.ultipro.com.