Organization: Sabin Vaccine Institute
Location: Houston, Texas
Program: Vaccine Development
Reports to: Director, Regulatory Affairs and Quality Assurance, Vaccine Development
The Program Officer, Quality Assurance, Vaccine Development will be responsible for quality assurance functions. This individual will work closely with counterparts in Washington, DC to oversee the Quality Assurance team’s mission, ensuring that vaccines developed are of high quality and all related materials, processes and personnel comply with the requirements. The incumbent will have an advisory role for non-regulated research studies that support Sabin PDP projects.
The Program Officer’s tasks will primarily be focused in pre-clinical vaccine development activities, and will include the oversight and improvement of new and existing documentation systems and databases. The individual will review, revise and create, as needed, Standard Operating Procedures (SOPs) to accommodate Sabin’s Core Quality System. This individual must demonstrate the ability to handle multiple priorities and interface with individuals from cross-functional areas of the PDP and external vendors. This individual will review and compile materials for technical transfers and CMC. The Program Officer will help in defining programmatic milestones and assessing critical resources and timelines related to quality concerns.
The Program Officer will report directly to the Director, Regulatory Affairs and Quality Assurance, Vaccine Development and work closely with all members of the Vaccine Development team and partners.