PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide.
PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against 15 different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.
PATH’s CVIA conducts vaccine development and associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.
The Document Control Manager will be responsible for overseeing the GxP Document Control Process. The Document Control Manager will report to the Global Head, Quality, and work closely with the Quality Systems Administrator and other Quality counterparts as well as the CVIA Clinical, Regulatory, and Drug Development teams, providing support in the use of the GxP controlled document process. This position will provide Veeva System backup support to the Quality System Administrator.
- Provide GxP document management expertise to the cross functional Quality Assurance team.
- Interface with departments/teams both internally and externally to ensure compliance in the Veeva system and associated modules.
- Support internal and external audits as part of audit readiness team representing Veeva System.
- Conduct routine document control activities including routing of documents through workflows, ensure formatting and proper use of templates, provide user level assistance in the document control processes as well as use of the Veeva EDMS system.
- Identify, generate and provide system-based performance metrics.
- Provide subject matter expertise to document control processes including interfaces with records management and information management systems and processes.
- Provide Veeva subject matter expertise as a back up to the Quality Systems Administrator.
- Represent QA Document Control on cross functional teams.