PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms: vaccines, drugs, diagnostics, devices, and system and service innovations that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs.
PATH Essential Medicines’ (EM) product development and introduction efforts focus on the leading causes of childhood deaths worldwide – pneumonia, diarrheal diseases, and malaria, as well as other global health priorities, such as polio and meningitis. EM works in partnership with communities, national health ministries, donors, international financing and regulatory organizations, vaccine manufacturers, particularly those in low- and middle-income countries, and many others to diligently design, develop, and improve new biologics and small molecule drugs that are safe, effective, affordable, and acceptable in the communities that need them most.
Reporting to the PATH Vice President of Essential Medicines (VP EM), the Global Head, Quality Unit (GH QU), will be responsible for building and leading the Quality function for EM. This position is responsible for establishing and implementing global quality systems and assuring GXP compliance and strategic risk mitigation across EM, both internally and in collaboration with PATH partners. The GH QU directs all quality activities and serves as the functional area representative from EM to PATH and to the external parties on all quality related matters. He/she is the key point person to address, escalate, and resolve quality issues raised internally and externally.
The GH QU leads and supervises a team of 6-8 individuals, including management of consultants/auditors as needed, to ensure project and business needs are met. Additional staff from the Clinical and Regulatory teams will support quality-related activities under the guidance of the GH QU and Associate Directors.
- Develop and advance the Quality function and systems to identify, communicate, and maintain appropriate quality norms for risk and issue management.
- Ensure quality philosophy and expectations are recognized, understood, and implemented across EM through continual communications, training, and knowledge management (including continuous learning, such as After Action Reviews (AAR)).
- Effectively collaborate and lead across all relevant disciplines (e.g., manufacturing, clinical, nonclinical, regulatory) to ensure an appropriate state of compliance and inspection readiness for drug and vaccine development.
- Develop framework for effective quality governance, inclusive of communication and escalation.
- Assessment of the impact of workload, capacity, resources, roles and responsibilities on quality for EM Quality Unit
- Liaise/point of contact with/to PATH on quality management systems and quality assurance topics
Quality Management Systems:
- Build, implement, and continuously improve quality systems and norms to support global, national and local regulatory compliance and expectations.
- Ensure Quality Management Systems are 21 CFR Part 11 compliant and validated.
- Development, advancement, communication, maintenance of quality elements (quality manual, standards, processes, etc.) to ensure that Quality Management Systems meets/exceeds performance metrics.
- Collaboratively manage the development, review, and approval of standards, SOPs, and other controlled quality management system documents in compliance with applicable regulatory requirements.
- Set and oversee effective processes, procedure, practices, framework are in place for knowledge management, documentation
- Refine and develop effective EM Quality Documents and create, install and implement training materials/workshops, as well as, the associated infrastructure for EM.
- Ensure adequate quality and oversight practices are in place and followed for internal work as well as third party vendors, CROs, service providers.
- Provides subject matter expertise and guidance on the phases, processes and techniques used to execute a Quality Assurance Plan across the GxPs and ensures these are implemented and adhered to as part of quality oversight.
- Develop, install and implement audit methods, process, procedures and training as it relates to EM QMS scope.
In addition, the GH QU routinely reviews and recommends revisions, as necessary, to the VP EM, on the EM Quality Management System, EM Quality Manual and EM Quality Standards and, routinely reviews and recommends revisions, as necessary, to the Global Heads of relevant Functional Areas, on the EM Quality SOPs and EM Quality Work Instructions and Quality Supporting Tools