Technical Lead

6 days ago

Beijing, Beijing, China PATH Full time

About PATH

PATH is a global nonprofit dedicated to achieving health equity. With over 40 years of experience forging multisector partnerships and expertise in science, economics, technology, advocacy, and more, PATH develops and scales up innovative solutions to the world's most pressing health challenges.

Center for Vaccine Innovation and Access

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.

Job Summary

We are seeking a Senior Technical Officer to join our team in China. The successful candidate will be responsible for strengthening cGMP activities and capabilities of vaccine and drug manufacturers in China and Southeast Asia, ensuring successful and sustainable outcomes.

Key Responsibilities

  • 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 building strong collaborative professional relationships with vaccine and drug manufacturers in China and in Southeast Asia.
  • 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.
  • Review plans against Quality Assurance and Quality Control requirements, including WHO Prequalification standards, and analyze risks, opportunities, and challenges, seeking solutions and supervising 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 manufacturers 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 SMEs/Consultant support in delivering set goals, as needed.

Requirements

  • A relevant bachelor's degree plus a minimum of 15 years of experience in vaccine/biologics/drug manufacturing under compliant environment (cGMP) 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 plans 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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