Position: Quality Assurance
AIDSVAX Project Oversight Team

Introduction:
Global Solutions for Infectious Diseases (GSID) is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. The AIDSVAX B/E Project involves activities related to the development and production of AIDSVAX B/E vaccine for clinical use, including internal and CMO activities. The AIDSVAX Project Oversight Team is responsible for planning, coordination, implementation and management of activities and resources associated with project goals for this and other HIV vaccine projects. Responsibilities of each team member are based on the project goals related to his/her area of expertise.

Responsibilities:

• Oversee the development, implementation, and maintenance of GSID quality assurance systems and activities.
• Conduct quality reviews and/or audits of potential and contracted CMOs, analytical labs, and raw material vendors.
• Provide expert evaluation of CMO quality systems and facilities to facilitate CMO selection.
• Coordinate the development and implementation of Quality Agreements with CMOs and other vendors.
• Oversee the generation and review of documents used in GXPs, both at GSID and CMOs and other vendors.
• Review and approve completed batch documentation for GMP production at CMOs, including QC documentation of release and in-process testing.
• Lead GSID investigations or oversee, review and approve CMO investigations and resolve potential product quality issues.
• Identify and evaluate fundamental issues for Quality functional areas through assessment of intangible variables, and interact with executive level management to influence policy making.
• Participate in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.

Required Experience:

• B.S. or higher degree in scientific discipline (biochemistry, chemistry, etc)
• 10+ years Quality Assurance experience in biotechnology or pharmaceutical industry
• Extensive experience auditing, evaluating, and managing CMOs, including participation in investigations and CAPAs
• Hands-on experience developing, implementing, and managing Quality Agreements with outside vendors
• Working knowledge of cGMP requirements for production of biologics
• Experience with oversight and evaluation of facility, process and assay validation
• Previous experience with Quality by Design (QbD) a plus

If you are interested, please send GSID your resume.

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