Manager, Global GMP Quality Assurance, Small Molecule 薪资面议
苏州 经验不限 学历不限
技能培训 岗位晋升 股票期权 带薪年假 五险一金
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职位介绍
工作职责: Provide Quality support for cGMP external manufacturing operations at CMOs Provide Quality support for CMC, Supply Chain and Regulatory CMC project teams Support Quality meetings between CMOs, partners, and BeiGene Provide Quality support for batch disposition of drug substance, drug product and finished product Drive, lead and troubleshoot quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions Provide Quality guidance and support for investigations and change controls Ensure CMOs are compliant for regulatory inspections and monitor progress during inspections. Provide audit/inspection support for CMO as needed Assess and revise, as needed, SOPs for GMP Quality functions and identify opportunities to streamline systems and processes Monitor performance metrics and drive continuous improvements of internal processes Advise on Quality Agreement content and support Quality Agreement implementation and updates Support regulatory filings and inspection as needed Other duties as assigned 任职要求: In-depth knowledge of GMPs Experience in working with external partners and/or contract manufacturing In-depth knowledge of Quality principles, concepts, industry practices and standards Excellent verbal, written and interpersonal communication skills Ability to work independently with scientific/technical personnel Knowledge of risk management tools is a plus Excellent interpersonal skills, including English listening, writing, negotiations, facilitations, attention to detail Interacts with all levels of BeiGene employees including CMOs Minimum of 5-8 years pharmaceutical or biotechnology industry GMP experience in quality Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint) Strong knowledge skills with GMP Quality Management System Ability to work on a computer for extended periods of time Travel as required ​

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