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. Together, we deliver measurable results that disrupt the cycle of poor health. Learn more about PATH’s work here: Imagine a new day.
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 has led numerous global partnerships, including the award-winning Meningitis Vaccine Project and the Malaria Vaccine Initiative, which helped develop the first malaria vaccine candidate recommended for pilot implementation.
The Regulatory Quality Lead will work closely with CVIA regulatory staff to ensure compliance with applicable policies, procedures, regulations, and guidelines, and develop and implement a quality management system, in coordination with Clinical and CMC/non-clinical functional areas in CVIA and counterparts in the Drug Development Program. The incumbent will also manage the regulatory documents in the document management system and perform other duties as assigned. The incumbent will report to the Head of the Regulatory Group in CVIA.
- Lead efforts in the Regulatory Functional Group to develop and implement a Quality Management System, in coordination with quality leads in Clinical and CMC/Non-Clinical Functional Areas in CVIA, and the Drug Development Group. These efforts will include
- Conducting gap analyses, prioritization of needs, and drafting a quality implementation plan
- Drafting SOPs for regulatory activities and developing systems for monitoring compliance
- Developing training materials and conducting training for QMS processes
- Participate in selection of a document management system for regulatory submissions, quality, and clinical trial documents
- Manage regulatory documents in the document management system
- Develop metrics for periodic assessment of implementation of quality management system in regulatory functional area.
- Conduct internal audits for proactive improvements and risk management.
- Host external SMEs and regulators for auditing CVIA regulatory operations.
- Bachelor’s degree plus 10 or more years of pharma/biotech industry experience, which should include at least 5 years of quality assurance experience
- Demonstrated knowledge of regulatory requirements, procedures, policies and guidelines related to clinical trials and product development and approval, including GCP/GLP/GMPs and 21 CFR Part 11 compliance
- Excellent communications (both orally and written) and interpersonal skills.
- Strong project management, business acumen and organizational skills.
- Ability to work with multi-site, multi-country teams.
- Advanced proficiency in MS Word, Project, Visio, PowerPoint and Excel.
- Excellent technical writing skills with high level of attention to detail.
- Demonstrated experience applying creative solutions to complex issues and problems.
- Ability to both implement and lead implementation of work plans.
- Ability to travel domestically and internationally.
- Industry experience in utilization of regulatory document management systems preferred.
- Accreditation as an Auditor preferred
For more information and to apply go here: https://path.silkroad.com/epostings/