PATH is a global organization that works to accelerate health equity by bringing together institutions, businesses, investors, and individuals to solve the world’s most pressing health challenges. With expertise in science, market development, 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. Learn more at www.path.org.
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 CMC Quality Manager will be responsible for overseeing GMP manufacturing, tech transfer, and related activities. The CMC Quality Manager will report to the Head of Quality Essential Medicines and work with other Quality counterparts as well as the CVIA Clinical, Regulatory, and Drug Development teams, providing leadership in addressing CMC Quality needs. This position will provide backup support to the Head of Quality Essential Medicines and other CMC Quality Manager(s).
- Managing or overseeing cGMP manufacturing, technology transfer and related quality activities.
- Managing documents including authoring SOPs, reviewing and approving batch records, SOWs and CAPAs/Change Control activities; CofAs, etc. within CVIA and at Vendors/CMOs/CROs ensuring quality activities are built into processes.
- Leading investigations and deviation root cause analysis, review, and approval as well as managing corrective actions and preventive actions (CAPAs) program associated with the manufacturing and analytical testing areas.
- Managing manufacturing support programs including raw materials and packaging component release for production.
- Managing validation and change control program for external manufacturing and analytical testing operations.
- Interfacing with departments/teams both internally and externally to ensure compliance in manufacturing including storage and distribution of materials to clinical trial sites.
- Supporting project teams as a Quality representative to provide advice and support from a quality perspective for aseptic, sterile clinical trial materials and commercial manufacturing projects or to engage with the appropriate Quality SME to provide advice and support to the team.
- Supporting the implementation of GLPs & cGMPs within CVIA and with PATH’s external partners.
- Contributing to the development and operation of the CVIA and PATH quality management systems.
- Providing administration activities for the electronic quality management system (eQMS) for audits, deviations, change control, SOPs and other QMS related cGMP activities.
- Conducting external audits to assess compliance to cGMP, WHO TRS and other relevant regulations and guidances
- Support internal and external audits for proactive improvements and risk management including generating audit reports and other types of reports for SLT review as required.
- Supporting and managing the building of a database of preferred vendors/CMOs with desired track record in compliance and technical capabilities.
- Reviewing Quality Assurance Agreements and Technology Transfer Agreements for suitability in working with Vendors/Partners/CMOs/CROs.
- Supporting the hosting of external SMEs and regulators for auditing CVIA quality operations which support CVIA portfolio.
- Conducting technical (process development/manufacturing/quality assurance) due diligence of potential partners.