苏州招聘

Overall Job Purpose
The Associate Director, Medical Quality is the quality advocate who participates in the strategic planning to strengthen quality management and quality oversight of medical portfolio across China


Key Job Objectives

1. Strategic Planning and Implementation
? Develop and implement risk management of medical portfolio in China
? Develop quality strategy for medical portfolio in China in collaboration with business leaders and regional quality leader
? Contribute to development of quality strategy for FIPNET operating model
? Provide strategic input ensure medical quality system is adequate to support medical portfolio in China

2. Quality Management
? Oversee effective implementation of quality management of medical portfolio in the China
? Ensuring corrective and preventive actions are taken to address quality issues (noted from self reporting/quality assessment/audit, etc)
? Provide quality metrics, trends and improvement needs as input for management review
? Participate in management review and quality council, influence/drive decisions and set initiatives to drive continuous improvement in the management of medical portfolio

3. External collaborations
? Provide quality consultations/interpretation and define the quality direction to comply with external and internal expectations
? Contribute to service operational guide/clinical management plan for the Lilly-external partner collaboration
? Represent Lilly as key quality member in joint Lilly-external partner collaboration quality council

4. Regulatory Compliance/Inspection Readiness
? Contribute to interpreting the ICH guidelines and other appropriate guidelines and regulations and act as an expert consultant for China
? Represent medical quality within China affiliate both internally and externally
? Perform ongoing risk assessment of quality of medical portfolio in China to identify performance gaps relative to current regulations and recommend corrective actions. Escalate significant issues to management
? Participate in both internal and external forums to ensure awareness of current regulatory environment and prepare for the future
? Implement necessary checks to review inspection readiness and compliance
? Facilitate audits and regulatory inspections, including follow-up.


5. Coaching
? Provide ongoing coaching and feedback to MQR
? Support individual technical and professional growth
? Support in empowering individuals to make logical decisions, resolve issues, and execute tasks
Job Requirements
? Bachelors Degree in scientific field
? Experience in medical research (min. 5 yrs) & quality management (min. 3 yrs)
? Extensive knowledge of GxP regulations, guidelines and standards applicable to medical research, including thorough knowledge of Lilly Quality Systems applicable to all areas of medical research
? Good knowledge of Quality Management Systems principles, including policies, procedures and processes
? Strong leadership and self management skills
? Strong communication (written and spoken), negotiation and analytical skills
? Global perspective and experience working across functional and geographical boundaries
? Demonstrated ability to identify root cause and manage difficult business / quality issues. Ability to separate critical from non-critical issues
? Ability to work effectively with all levels internally and externally including ability to present sensitive material appropriately to senior management
? Customer focus

美国礼来公司（Eli Lilly and Company）是一家全球性的以研发为基础的医药公司，创立于1876年，总部位于美国印地安那州印第安纳波利斯市。2008年礼来全球销售额突破200亿美元，业务遍及全球 143 个国家和地区，雇佣员工四万多人。

礼来于1918年来到中国，将其第一个海外代表处设在上海。在1993年重新回到中国。已成为业界增长速度最快的制药公司之一。至今，我们在苏州拥有一家独资企业：礼来苏州制药有限公司，30多家办事处，员工已超过1400人。 礼来全球研发中国总部也于2008年10月15日在上海张江高科技园区正式成立。

礼来在中国的许多医药领域居领先地位，如抗感染、中枢神经系统、肿瘤、内分泌等。她的创新药物，不仅挽救病人生命、提高了大众的生活品质，同时也为患者、保健提供者和支付方创造了价值，降低了疾病治疗的成本。

作为全球十大制药企业之一, 礼来始终致力于履行企业社会责任。礼来每年投入巨额资金用于回馈社会。由于礼来在企业社会责任方面的突出贡献，礼来已连续三届荣获《商业周刊》杂志“最慷慨的公司”称号。据《慈善纪事》(Chronicle of Philanthropy)显示，在接受调查的91家美国大型公司中，礼来2006年的捐献数量位居第六。2007年礼来公司慈善捐赠总额约为3.15亿美元，其中包括价值约2.4亿美元的产品捐赠，均用于患者援助计划和国际人道主义事业。2007年公司的捐赠总额大约占公司调整后收入（税前）的6%，再次使礼来成为世界最乐善好施的公司之一。

在中国，礼来也积极推动各项社会公益事业，善尽社会责任，致力成为企业公民的典范。2008年礼来公司在华公益投入总计人民币四千余万元。在南方周末2008中国企业社会责任评选中，礼来中国荣膺“2008世界500强企业慈善公益榜”第3名。

礼来公司有着注重内部培养的用人之道，我们愿意招聘处于职业发展初期的员工加入礼来共同成长并长期服务。当公司出现岗位空缺时，我们能够从内部提拔员工任职或转岗。在礼来中国，我们的管理层有95%来自内部提拔。我们还创建了一种注重员工培训与发展的文化和系统。因此，在业界，我们有“礼来大学”之美誉。我们的培训系统，在职辅导系统，和接班人计划尤其为人们所广为称道。 礼来有着注重绩效和行为并重的文化传统，同时为员工提供全面的薪酬福利保障。 我们以最高道德标准管理我们的业务并在日常工作中要求我们所有的员工。我们相信符合最高道德标准的行为将最终使我们的公司和员工受益。

礼来对中国市场有着中长期的发展战略，我们对这个市场雄心勃勃。从2006开始， 礼来公司启动彩虹计划在内分泌， 抗肿瘤及中枢神经领域进行扩招， 我们的员工队伍已增加了40％，达到了1100多人， 为公司的发展做出来巨大的贡献。从2009年到2013年， 礼来将会进一步加大对中国的投资力度， 礼来中国将进行前所未有的扩张计划。

如果你一直想加入这家有着良好声誉的公司， 现在， 机会之门正在敞开！我们寻求年轻的你， 优秀的你， 自信的你加入我们， 和礼来一起共同成长。无论你是经验丰富的专业人士， 还是胸怀壮志的应届毕业生，相信礼来的内部提拔机制和在职培训系统能够给你的职业和人生带来彩虹般的精彩。 如果你够自信, 够优秀,充满对成功的渴望, 来吧，加入我们， 礼来将助你成就梦想！