Sharon Wang

QA

1. leads projects and solves challenging issues especially related to analytics and quality to ensure high‐quality delivery of API related projects under applicable cGMP requirements. 2. Leads and drives on‐going training and development to colleagues regarding cGMPs. Identifies, evaluates and implements applicable new regulatory and company requirements to enhance quality competence. 3. Take oversight for quality related activities at BI CoC (Center of Chemistry), including quality management review, quality system, laboratory system as well as computerized system, etc. and to identify gaps and risks and find solutions/mitigations to reduce the risk level. 4. Host and coordinate audit and track the following up actions. 5. Lead all quality related activities and culture cultivation at CoC, including data integrity, right‐first‐time, risk assessment, walk‐in‐my‐shoes, failure culture, etc. 6. Be responsible for reviewing and approving the report of investigation, OOS/OOT/OOA/ATY, deviations, change control, CAPA, making sure all quality related activities are well carried out and documented. 7. Initial and review/approve SOPs related to quality system, data integrity and analytical activities. 8. Provide leadership, direction and support to the people within the quality department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.

1.         Lead and work with team members to establish and maintain the quality system to make sure all the projects are on the track. 2.         Be responsible for the data integrity and computerize system activities related to make sure all the activities are under GMP requirements. 3.         Be responsible for ensuring that raw material, packaging materials and intermediate, bulk and finished product are approved or rejected, stored, distributed and subsequently handled according to defined procedure or specification. 4.         Manage the tech transfer for DS and DP activities. 5.         In depth knowledge of process development, pilot, scale-up and process validation for DS and DP. 6.         Initial and review the SOPs in R&D center, referring the SOPs from synthesis lab, analysis lab, formulation lab, Non-clinical and clinical, etc. 7.         Be responsible to approve the investigation, OOS/OOT/OOA/ATY, deviations, CAPA, making sure the corrective and preventative actions are carried out and documented. 8.         Review and approve the records of method development/validation/transfer/verification, stability samples for DS and DP to ensure all the documentation are correct. 9.         Host and coordinate the CFDA audit and reply the response. Manage internal regulation audit to make sure all the documents generated are correct for filing of FDA and CFDA 10.     Review and approve the CoA, investigation reports according to defined procedure or specification, ensure accuracy and reliability of testing figures. 11.     Good communication skills and fluent English both in verbal and written. 12.     Be responsible for training new staff.

1. Be responsible for establishing and maintaining the quality system to make sure all the projects are meet the requirements. 2. Lead team to support the drug product and drug substance manufacturing at Pilot scale to make sure operation meet related compliance as well as customer requirements. 3. Be responsible for reviewing and approving investigation, deviation, CAPA, OOS/OOA/OOT and change control to ensure all the actions are carried out and documented. 4. Be responsible for ensuring that raw material, packaging materials and intermediate, bulk and finished product are approved or rejected, stored, distributed and subsequently handled according to defined procedure or specification. 5. Accumulate experiences from the audits of FDA, EMEA and CFDA. 6. Take part in FDA audit and internal audit; conducting routine inspection for laboratory and ensure the lab compliance. 7. Be responsible for building 5S lab to make sure all the actions are in good condition. 8. Review logbook of equipment and rooms regularly. 9. Perform elegance checking on the product and take release sample, retention sample per the instruction. 10. Be responsible for analytical related SOP’s writing, revision and reviewing. 11. Review and approve the records of method development/validation/transfer/verification and stability study for DS and DP to ensure all the documentation are correct. 12. In depth knowledge of test methods, SOP, protocol and other computer management system (LIMS, Velquest, Empower, etc) and provide training on these to new comers. 13. Establish and maintain good working relationships with other group leaders and related departments. 14. Be responsible for training new staff.

1. Familiar the regulatory submission and the procedures of drug registration. 2. Establish the analysis method and approval processes for new chemical entities and generic drug. 3. Author whole pack of submission documents, search clinical material for the filing. 4. Hand-on experience on HPLC, GC, UV, Dissolution tester and other instruments. 5. Establish test method validation and specification. 6. Establish analytical methods for assay/potency, impurities and residual.