Senior Technical Officer

1 week ago

Beijing, Beijing, China PATH Full time
Job Title: Senior Technical Officer

PATH is seeking a highly experienced Senior Technical Officer to join our Center for Vaccine Innovation and Access (CVIA). The successful candidate will be responsible for strengthening cGMP activities and capabilities of vaccine and drug manufacturers in China and Southeast Asia.

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 way of building strong collaborative professional relationship with vaccine and drug manufactures 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. 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.
Requirements:
  • 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.

Location: China

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