Jessie Yang
Senior External Supply Qa Manager @Sandoz
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WORK HISTORY
Senior External Supply Qa Manager @Sandoz
Same role as previous job in Novartis as External supply QA. Sandoz spined off from Novartis in 2024. 8 years supplier quality management experience for Sterile/ Non-Sterile finished dosage form products, Sterile/Non-Sterile API including sterile liquid injection, lyophilization powder for injection, sterile powder, sterile BFS eye drops, oral liquid, tablets, capsules for CMO & BD & L business (domestic & oversea suppliers) for global markets.o New supplier development/qualification and QA launch preparation activities for sterile finished dosage form products for US, RoW markets.Successfully launch a CMO sterile liquid for injection oncology product for US market, a BD & L sterile lyophilization powder for injection antibiotic product for CAC & EC markets, prepare launching for a sterile eye drops product for US market and a powder filling sterile product for MX market.o Routine quality oversight for existing domestic and oversea sterile/non-sterile Finished dosage form suppliers for EU, US, and RoW markets.o Routine quality oversight for existing domestic sterile/non-sterile strategic API suppliers for EU, US, and RoW markets.
EDUCATION
East China University of Science and Technology
Master's degree, Chemical Technology/Technician
SKILLS
ABOUT JESSIE YANG
o 18 years’ quality management experience in international pharmaceutical companieso 8 years’ experience in external supplier quality management for CMO & BD & L business (Non-sterile/Sterile API, Non-sterile/Sterile Finished dosage form products, including oral liquid, tablets, capsules, liquid injection, lyophilization powder for injection, sterile powder, sterile eye drops etc.) o 3 years’ qualified regional supplier auditor experience (API, excipients, intermediate/starting materials for API, packaging materials, and contracted lab) o 2 years’ QA operation team leader experience o Strong knowledge of global GMP quality regulations & guidelines (ICH guidelines, EU GMP, Chinese GMP, US FDA, WHO, PIC/S, PDA, IPEC, ISO 9001, APIC etc.) o Strong knowledge of sterile products o Strong manufacturing experience in API chemical synthetic process, veterinary drug product (premix, powder) o Strong problem solving/result driving ability, leadership for supplier management o Good communication skills within global cross function stakeholders and with external suppliers o Fluent oral and good English written skills
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