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Associate Director, Global GCP Quality

2 months ago

Nairobi, Nairobi Area, Kenya International AIDS Vaccine Initiative Full time

ABOUT THE COMPANY

The International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Founded in 1996, IAVI works with partners in 25 countries to research, design and develop AIDS vaccine candidates. The organization also conducts policy analysis and serves as an advocate for the AIDS vaccine field. It supports a comprehensive approach to addressing HIV and AIDS that balances the expansion and strengthening of existing HIV prevention and treatment programs with targeted investments in the design and development of new tools to prevent HIV. IAVI is dedicated to ensuring that a future AIDS vaccine will be available and accessible to all who need it. The organization relies on the generous donations of governments, private individuals, corporations and foundations to carry out its mission.

JOB SUMMARY

Are you a GCP Quality leader eager to make an impact in a mission-driven organization?IAVI is seeking an Associate Director, Global GCP Quality to partner with the Sr. Director, Clinical QA, ensuring clinical development operations compliance, and adherence to IAVI and industry standards. The Associate Director will facilitate the development and implementation of the GCP audit plan, helping to drive success of the global QA audit plan, ensuring appropriate processes, procedures, and controls are in place. Help translate science into global health solutions as an Associate Director, Global GCP Quality at IAVIEducation and Work Experience:Bachelor's degree in life sciences or related field is required; Advanced degree is highly preferred.Minimum 8 years of experience in clinical research is required.Minimum of 4 years' experience in quality assurance is required.Experience working with project budgets, contracts, Quality Management Systems (Veeva QMS), and Project Management System (Smartsheets) is required.Experience with auditing and/or quality oversight is required.Qualifications and Skills:Experience working with industry standards and research operations related to vaccine development.An exceptional knowledge and understanding of electronic quality management systems, with specific reference to the audit process, is desirable.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.

RESPONSIBILITIES

Initiate the development and oversee the implementation and maintenance of the annual Clinical Development GCP audit plan.Serve as key liaison for Clinical Development for audit requests.Coordinate, facilitate and administer meetings required in support of the GCP annual audit plan.Confirm budget availability and allocation for audits requested with the QA Budget representative.Identify Auditor availability and submit resource assignment proposal for director's approval:Support the identification and qualification of new consultants.Maintain a consultant's records database.Oversee consultants training on IAVI SOPS.Liaise with IAVI contracts and finance to get the required contracts and financial agreements in place prior to audit initiation.Manage and oversee the audit management process according to relevant SOPs, including:Contacting the auditee in planning phases for planning information.Coordinating internal planning meetings.Serve as primary liaison with the Auditor assigned to the audit.Coordinating audit workflow according to agreed timelines and schedule.Oversee quality of audit process documentation by approving all audit life cycle documents in the QMS.Participate in meetings relevant to this process as indicated.Compile GCP audit plan metrics on quality and progress on a quarterly basis.Prepare vendor client satisfaction surveys for approval by the Director.Develop and improve current procedures and tools to support the GCP audit process.Participate in executing the audit plan as delegated.Perform other tasks as assigned by the manager.

REQUIRED SKILLS

Project management, Budgeting, financial planning, Reporting, Ability to coordinate, Planning

REQUIRED EDUCATION

Bachelor's degree