Senior Technical Officer
4 weeks ago
PATH is seeking a highly experienced Senior Technical Officer to join our Center for Vaccine Innovation and Access. This role 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 and Southeast Asia.
- Provide technical and manufacturing Quality support for ensuring robust and sustained manufacturing of quality vaccines and drugs.
- Build strong collaborative professional relationships with vaccine and drug manufacturers.
- Provide technical guidance to vaccine and drug manufacturers to improve and maintain technical capabilities.
- Review plans against Quality Assurance and Quality Control requirements.
- Conduct Mock Inspection and technical due diligence of vaccine and drug manufacturers.
- Provide GMP and Quality System training.
Requirements:
- A Relevant bachelor's degree plus a minimum of 15 years of experience in vaccine/biologics/drug manufacturing under compliant environment (cGMP).
- Planning, conducting, collaborating, managing, or overseeing cGMP manufacturing, and Quality, and conducting due diligence activities.
- Experience with pharmaceutical quality operations and auditing.
- Knowledge of vaccine, drug and biologics development and manufacturing (cGMP) in developed and developing countries.
- Proven ability to conduct internal or external quality assurance auditing of manufacturing facilities and operations.
- Experience managing complex international projects involving vaccines, drugs, or biologics.
- Written and oral communication skills in Chinese and English.
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