长沙招聘

GENERAL SUMMARY

Regions are growing in terms of IS requirements following the sites activity increase. In a context of Global Solutions deployment at regional level, ISQ&C representatives at regional level aim :

to identify and assess the relevant risks associated with the global solutions deployment
to contribute to the risk mitigation (GxP, SOX, Security ...) through the definition and implementation of appropriate actions, in accordance with the IAIS repository and its recommendations
to alert the ISIA Risk Committee on IS/IT related issues that may raise to critical risks : e.g. Phenix sanofi Global Quality tool


KEY RESPONSIBILITIES AND ACTIVITIES

At Regional Level, in a context of deployment of IS/IT solutions, Regional ISQ&C Representative is the regional relay of Compliance & Risk Management (C&RM) activities which are organized around the following pillars:

IS Quality and Compliance:
Responsibility over IS Quality & Compliance activities for regional legacy solutions, support to Regional IS teams and industrial sites in the implementation of "Quality & validation deployment packages" for Global Solutions.
Ensure solution deployment security for "go live" phase:
Through implementation of risk mitigation measures defined in the CAPA, and commensurate with the Project deployment risk assessment
Through the assistance to industrial sites in the Authorization For Use check list execution
Audit and Internal Control :
Contributes to the execution of regular checks on the SOX compliance level for day to day operations performed in the relevant systems,
Performes IS vendor audits
Compiles and issues reports detailing conclusions and providing recommendations for improvements. Serves as liaison for all internal, external audit and regulatory agencies.


Risk management & Security: in conjunction with IS/IT Risk Management department and site Risk Management Head, facilitate the identification of any threats on IT system that may impact achievement of business objectives, following the C&RM framework

Methods & tools: Assistance to our regional partners (Project teams, sites counterparts) in the implementation of the applicable IA/IS repository (SOP's, WIs, tools) developed by C&RM Methods & tools department

IS IA Risk Management Committee (RMC) : Regional ISQ&C representative contributes to the RMC and acts as regional point of contact
providing Alerts to the Risk Committee on IS/IT related issues that may raise to critical risks
contributing to the IS/IT Risk Management Report for the region

Interactions with the key regional actors and organization, as well as close cooperation with the IS Quality & compliance department Global IS centers are crucial to ensure success of the Regional IS Quality & Compliance Representative



Education /experience

Engineer, chemist or pharmacist
5 to 10 years experience in information technology risk management, audit and/or compliance, with significant experience in information technology controls review; experience in audit organization preferred
Project Management experience
GMP / Validation / Security in Regulated Industry experience
Internal Control knowledge
Skills
Technical skills
Significant knowledge of IS/IT processes and controls and an understanding of risk and quality control and assurance functions
Strong process orientation and understanding of operations and technology
Regulation, Standards and Frameworks :
FDA cGMP’s, EU GMP’s, Sarbanes-Oxley Act, the European Union Directive on Data Protection, ISO/IEC 27001/27002, COBIT, ...
Soft skills
Significant analytical and critical thinking skills
Communications and/or Public Speaking
Ability to contribute to multiple projects concurrently
Ability to build and maintain collaborative working relationships with IS/IT and Business personnel
Negotiation Skills and/or Personal Selling
Project Management/Time Budgeting

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
- 全球100,000余名员工，业务遍及100个国家
- 新兴市场实力均衡，表现强劲，位列***
- 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
- 疫苗领域的领导者
- 领先动物保健市场
- 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
  
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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