Roles and Responsibilities:
61 Initial assessment of the potential suppliers (in terms of GMP compliance/quality management)
61 Quality audit of the new and existing suppliers/manufacturers (including preparation, communication, organization of the audit, performance of the audit and CAPA management and follow-up)
61 Alignment on the quality requirements (specifications) with the suppliers/manufacturers
61 Signing/updating quality agreements with the supliers/manufacturers
61 Management of claims to the suppliers/manufacturers (including assessment of the investigation results, assessment of CAPA, for-cause audits/visits, development and implementation of quality improvement plans for the suppliers)
61 Development of the quality management system of the ADV/Anabion (SOP writing and updates, establishing processes for suppliers management, supplier change control management, claims management, maintenance of the suppliers/manufacturers list and regular audits schedule)
61 Periodic evalution of the quality of the suppliers/manufacturers performance, development of improvement plans, updating supplier documentation (licences, certificates)
61 Review and approval of CoA/CoCs and other quality documentation from the suppliers/manufacturers
61 Support of communication between BIOCAD QA and suppliers/manufacturers, requesting necessary documentation/quality certificates on request

Education:
Bachelor’s degree in quality management or pharmaceutical science or biotechnology or other related field

Qualifications:
1. Master's degree in a related field preferred.
2. Proven experience working as quality assurance specialist responsible for supplier management for at least 2 years.
3. Experience in supplier quality audits.
4. Additional certification in the field of quality auditing.
5. Strong knowledge of cGMP/cGDP requirements.
6. Strong knowledge of the industry and market conditions.
7. Excellent written and verbal communication skills (English and Chinese is a must).
8. Exceptional interpersonal and teamwork skills.
9. Able to travel to meet vendors and suppliers as necessary.
Result-oriented.