Associate Director, Global QA NGO Job IAVI
NGO Jobs, International AIDS Vaccine Initiative (IAVI) Jobs.
Key Responsibilities:
- 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.
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