合规经理

岗位职责

工作职责:1.与工厂负责人和高层领导团队一起完成中国区的战略和运营目标。2.领导质量团队不断提升公司质量文化和意识。引领团队保障公司的可持续化运作。3.建立，领导并维护质量体系，以符合当前国际法规和标准要求的质量体系支持生产活动。4.独立开展工作，对产品的质量管理负责；有管控公司产品质量问题的职责。5.拥有全球GMP法规方面的丰富知识，负责公司全体员工的GMP法规培训，并评估培训结果。任职要求：1.制药、生物、化学及相关专业，本科及以上学历；2.熟悉中国、美国和欧盟的GMP要求以及数据可靠性的相关法规；3.曾主持或参与国外GMP认证、审计等工作经验者；4.至少10年生物制药行业工作经验；5.英语读写熟练，听说能力优秀者优先。Jobresponsibilities:1.PartnerswiththeSiteManagerandSeniorLeadershipTeamtodeliverthestrategyandtargetsassociatedwithoperationsinChina.2.LeadanddirecttheQualityorganizationtocontinuouslyenhancetheQualitycultureandmindsetwithintheorganization.Leadanddirecttheteamtoensuretheorganizationsustainability.3.Develop,direct,andmaintainqualitysystemsinsupportofmanufacturinginamannerconsistentwithglobalqualitysystems,requirementsandstandardsandcurrentregulatoryrequirements.4.HaveoverallresponsibilitiesforproductQualitymanagementandindependentlyperformduties;havethequalitymanagementauthorityoverproductissueswithintheenterprise.5.ResponsiblefortrainingallstaffonGMPregulationsandevaluatonofthetrainingresultbasedoncomprehensiveknowledgeofglobalGMPregulations.JobRequirements:1.Pharmaceutical,biological,chemicalorotherrelatedmajors,Bachelor'sdegreeorabove;2.ComprehensiveknowledgeofGMPanddataintegrityrelatedregulationsinChina,USandEU;3.Haveexperienceinleading/participatingininternationalGMPinspections,audit,trainingandotherwork;4.Atleast10yearsofexperienceworkinginthebiopharmaceuticalindustry;5.ProficientinEnglishre