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.