- Strengthen cGMP activities and capabilities of vaccine and drug manufacturers in China (70%) and in Southeast Asian countries (30%) ensuring that regulatory inspections (NRA, WHO) yield successful and sustainable outcomes.
- Provide continued technical and manufacturing Quality support for ensuring robust and sustained manufacturing of quality vaccines and drugs that meets local and global demands.
- Become a resource and a trusted partner by way of building strong collaborative professional relationship with vaccine and drug manufactures in China and in Southeast Asia. Leverage external SMEs/Consultants as needed to achieve the objective.
- Provide technical / manufacturing guidance to vaccine and drug manufacturers and help them improve and maintain technical capabilities for robust and sustainable operation that supplies forecasted demands. Help to pursue WHO prequalification or maintain WHO prequalification status.
- Review plans against Quality Assurance and Quality Control requirements including WHO Prequalification standards. Analyze risks, opportunities, and challenges, seek solutions, and supervise project implementation to ensure achievement of targeted milestones.
- Provide strategic and technical guidance to the PATH China office and Global CVIA Quality and CMC functions.
- Conduct Mock Inspection, technical (process development/manufacturing/quality assurance) due diligence of vaccine and drug manufactures as required.
- Review remediation and CAPA plans, as necessary.
- Provide GMP and Quality System training, as necessary.
- Determine GMP Certificate suitability.
- Provide technical review of pharmaceutical plans and technical documentation relative to vaccine and drug manufacturing facilities.
- Engage as needed SMEs/ Consultant support in delivering set goals.
- Time allocation: 70% for China and 30% for the rest of Asia- 70% for vaccines and 30% for drugs.
- A Relevant bachelor's degree plus a minimum of 15 years of experience in vaccine/biologics/drug manufacturing under compliant environment (cGMP) that is suitable for regulatory submission and licensure.
- Planning, conducting, collaborating, managing, or overseeing cGMP manufacturing, and Quality, and conducting due diligence activities.
- Experience with pharmaceutical quality operations is critical for the job as is auditing experience. Certification from a Quality Organization (CQA from ASQ, for example) is a big plus.
- Knowledge of vaccine, drug and biologics development and manufacturing (cGMP) in developed and developing countries is a plus.
- Experience in applying US and international (including WHO) quality requirements in the context of regional and international regulatory expectations.
- Proven ability to conduct internal or external quality assurance auditing of manufacturing facilities and operations and in developing remediation plan for execution.
- Experience managing complex international projects involving vaccines, drugs, or biologics.
- Experience in technical report review.
- Written and oral communication skills in Chinese and English are required.
- Ability to travel internationally and within China up to 50 percent.
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Senior Technical Officer - Beijing, 中国 - PATH
描述
PATH current employees - please log in and apply
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world's most pressing heath challenges.
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.
Responsibilities:
Required Experience:
Location: China
