Andy Zhao

­ As the department head, oversee all aspects of quality activities for GMP operations, primarily external GMP operations in business partners, CDMOs and other related vendors. ­ Participate in the selection of suitable contract manufacturers and laboratories; develop and track contractor performance and quality metrics for products, collaborate with other functions and agree service contracts with suppliers. ­ Interface with partners' & suppliers' quality departments to negotiate and sign quality agreements. ­ Lead GMP audits of CDMOs, including suppliers' site facilities and equipment, quality systems, documents system, manufacturing, lab, persons, outsourcing activities, etc. Ensure that contract manufacturing complies with cGMP standards. ­ Manage contracted suppliers to ensure compliance with company pipeline propulsion, including documents system, deviation management, change control, investigation, CAPA, quality risk management. ­ Interact effectively with contracted manufacturers and internal multidisciplinary teams to provide technical support for product quality decisions. necessary training between parallel departments. ­ Review/approval of batch production records, batch inspection records, validation documents completed by CDMOs. Release of materials and finished products.etc. ­ Work with relevant functional departments and design institutes to complete the design of the company's factory facilities (conceptual design, preliminary design, detailed design), provide relevant URS, compliance support and complete the selection of facility equipment. ­ Conduct cGMP compliance audits of facility designs. prepare Validation Master Plan VMP, Quality Risk Plan QRP. ­ Complete the daily work of the QA department and cooperate with other functions of the company.

­ Presiding daily work of the QA department; Partner with other departments to ensure cross-departmental QA alignment. ­ Provide technical expertise for product quality decisions. ­ Develop and track the quality metrics for contractor performance and product quality. ­ Design a quality system document framework that is appropriate to the company's current situation and break it down to each department to draft then make an audit.

­ Formulation of the company's quality policy and quality objectives. ­ Presiding the daily work of QA department and validation department. ­ Responsible for the establishment of the quality system and presiding over the revision of the new GMP documentation system. ­ Review and approve all types of GMP documents, etc. ­ Responsible for the release of GMP materials and products. ­ Daily coordination work, supervision, audits, evaluations, personnel assessment work, etc.

­ Lead the upgrade and innovation of the company's quality system, on the bases of which our company successfully obtained the first GMP (2010) certification. (Overall adjustment and upgrade of the company's documentation system to comply with the requirements of the GMP (2010). With the support of the company's upper managers, the restructuring of the company's organization, the adjustment of departmental functional boundaries, the definition of work content and the adjustment of work processes are realized. Independent draft of the GMP certification framework papers and completion of the submission. ­ Chair the daily running of the QA department as the department head: team of document, team of QMS running & training, team of validation, team of compliance, team of release. ­ Training management, GMP documents review, arranging internal and external audits, quality coordination, supervision and evaluation. ­ Release audits of products for clinical and commercial uses in accordance with GMP requirements and SOPs. Arranging for Lot Release. ­ Daily coordination work, departmental budgets, staff appraisals. ­ Preparation of the company's Quality Manual.

­ Organize the follow-up of FAT, commissioning, IO, OQ, PQ (factory facilities+HVAC, purified water systems, injection water systems, compressed air systems, buffer preparation system, wash-dry-fill systems, RABS, MHS&DHP, etc.) Carried out by equipment suppliers and validation consultancy suppliers. ­ Review validation protocols and validation reports, including FDS, DDS, FAT, URS, etc. ­ Organize employees to draft QA department documents and then review them. ­ Lead inter-departmental horizontal liaison and coordination.

­ QA technician to QA engineer: On-site supervision and inspection of antibody DS (cell culture, purification) manufacturing, review of BPR (batch production records). Statistics and analysis of quality indicators. Deviations, CAPA, changes, retrospective analysis, etc. Follow up and learn the validation & qualification of HVAC, pure water system, water for injection system (under construction for the 3000L*2 stock solution production line in Area B). ­ Validation engineer: Drafting of validation plans for DS manufacturing sections, Break down, organize and coordinate the details of the validation process. Summarize, analysis and write reports (CHO cell culture process validation, antibody purification process validation, equipment cleaning validation). ­ Cyclic PQ of HVAC systems (A+B level, RABS, etc.). ­ Arrange for subordinates to carry out testing of MHS&DHP(Moist Heat Sterilization、Dry Heat Processes Used for Depyrogenation and Sterilization）PQ.