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 quality 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 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.
Qualifications and Skills:
Strong knowledge and understanding of industry standards and research operations as pertinent to vaccine development is required.
Experience working with quality management systems is required.
Experience working with electronic data and records in CFR21Part11 compliant environments is highly desirable.
Experience as auditor of public health trials is highly desirable.
Experience working in remote-, virtual-, global-, teams, is highly desirable.
Apply via :
recruiting.ultipro.com
