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1. Bachelor’s or master’s degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field.
2. A minimum of 10 years working in biopharmaceutical or pharmaceutical or industry inclusive of Quality Assurance or Quality Engineering experience. Prior upstream/downstream experience in drug biomanufacturing is preferred.
3. Understanding of drug manufacturing QMS requirements and regulatory requirements including but not limited to NMPA regulations, FDA 21 CFR 210 & 211, PIC/S and application to the manufacture of biopharmaceuticals.
4. Exceptional analytical, problem solving & root-cause analysis skills.
5. Good English written and verbal communication skills.
6. Demonstrated collaboration & conflict resolution skills.
7. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies.