Sheng Poon

Senior Qa Manager @Ionis Pharmaceuticals, Inc.

San Diego, CA, US

Ensure the compliance of Ionis\' manufacturing and testing activities with respect to applicable domestic and international regulatory cGMP requirements, and industry guidelines (e.g. EU, FDA, HC, ICH, MHLW, TGA, etc.), and to Ionis\' QMS and SOPs• Provide quality oversight and support (i.e. decision-making) to contract manufacturing organizations with respect to Drug Product (DP) formulation, sterile filling, and visual inspection activities• Review batch records, quality control data and testing records, and perform lot disposition activities for Intermediates, Drug Substance (DS) and Drug Product (DP)• Review and provide input (e.g. failure analysis, problem solving, and risk assessment and mitigation) for quality activities and events related to the manufacture or testing of Intermediates, Drug Substance (DS) and Drug Product (DP)• Resolve complex quality events and issues [e.g. deviations, investigations, Out-of­ Specification/ Out-of-Trend investigations, or any other quality events related to the manufacture or testing of Intermediates, Drug Substance (DS) and Drug Product (DP)]• Perform internal audits of Ionis\' cGMP operations and perform external audits of lonis\' suppliers and contract manufacturing organizations (CMOs) and testing laboratories, as assigned• Review stability data and testing records for Drug Product (DP)• Develop, implement, and deploy enhancements to Ionis\' Quality System procedures• Support domestic and international regulatory authority as well as partner and Qualified Person (QP) audits or inspections

UC San Diego

Bachelor's degree, International/Global Studies