【苏州 (Senior) Quality Manager (REQ-10079049)招聘】-诺华集团（中国）苏州招聘信息-猎聘

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Recruiting Experience Partner · 诺华集团（中国）

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职位介绍: The Quality Manager is responsible for quality oversight of development project in global CMC team. Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations. Major accountabilities: •Ensure quality oversight for the assigned development projects with strong quality guidance, scientific and technical expertise. Support TRD CMC team with respect to all quality aspects. •Review and approval of GMP relevant documents and decision making up to drug substance with authority of Quality Manager. Perform technical release decision of drug substance with the delegation of FvP/RP. •Manage and support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc. Review and approve quality deliverables to ensure compliance. •Review and approval of qualification / validation and release documents of facility, manufacturing equipment, laboratory instruments and IT systems for GMP use. •Quality incident management including deviation, OOS/OOE and escalation. Assist with root cause investigations and Support the development of corrective and preventative action plans (CAPA), including monitoring status to ensure issues are addressed, completed and documented. •Change control management to ensure that all the aspects and full impact are appropriately evaluated, addressed and documented. •Review or Approval of Third Parties and documents related to Third Party Management •Establish and maintain QA documentation systems such as applicable global standard, SOP’s, Site Master File. •Provide support to TRD line functions in GMP related topics as per area of responsibility. Key performance indicators: •In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections. •Maintain sound working relationship with internal customers and external partners. •Meet quality and timelines in all projects. •Act in accordance with Novartis standards in particular: cGMP, ethical, health safety and environment (HSE), and information security (ISEC) Minimum Requirements: •Bachelor (＞ 5 years’ pharma quality or operations). Masters (＞ 3 years’ pharma quality or operations). Experience in xRNA filed is preferred. •Broad knowledge of cGMP, working experience in technical drug development, manufacturing, analytics or quality. •Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines. •Good organizational and decision-making skills. Good and proven ability to analyze and evaluate cGMP compliance. •Project Management •Excellent communication skills in global environment. Skills: •Agility. •Analytical Development. •Audit Management. •Auditing. •Business Partnering. •Change Control. •Continuous Learning. •Health Authorities. •Influencing Skills. •Knowledge Of Capa. •QA (Quality Assurance). •Quality Management. •Risk Management. •Root Cause Analysis (RCA). •Self Awareness. •Six Sigma. •Sop (Standard Operating Procedure). •Technological Expertise. Languages : •Fluent English required (oral & written). 为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。无障碍及便利设施：诺华承诺与残障人士共事并为他们提供合理的便利设施。如果您由于健康状况或残障，在招聘过程的任何环节需要合理便利设施，或者为了履行职位的基本职能，请将您的相关需求告知我们的招聘经理。加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华招聘社交媒体账号。职位要求： Operational Excellence Collaboration Problem Solving Skills (Inactive) Digital saviness (Inactive) Business Partnerships Communication Skills (Inactive) Data Integrity Managing Ambiguity Leadership Regulatory Requirements knowledge (Inactive)

其他信息: 所属部门：Development

公司简介

关于诺华诺华集团致力于为患者及社会提供创新医药健康解决方案，以满足其日益变化的健康需求。总部位于瑞士巴塞尔，诺华集团拥有多元化业务组合以**地满足这些需求，包含创新药品、眼科保健和成本节约型非专利药品。诺华是**在上述各领域均处于**位置的公司。2015年，集团净销售额达494亿美元，集团研发投入约为89亿美元（去除减值及摊销后为87亿美元）。诺华集团拥有近119,000名全职员工。诺华的产品覆盖全球180多个国家和地区。如需更多信息，敬请登录公司网站************************ “诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务，致力于提高中国人民的健康水平和生活质量。诺华在中国拥有诺华制药（创新药）、爱尔康（眼科保健）以及山德士（非专利药）等业务，全国建有三大生产基地，并在上海及江苏设立了两大研发中心。从研发到生产销售，诺华以多元化的业务组合，全面服务中国百姓健康。目前，诺华在中国全资或控股的公司共有六家。诺华在华雇员超过7,700人。如需更多信息，敬请登录公司中文网站***************************

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公司信息

诺华集团（中国）

关注

企业行业：制药

人数规模： 500-999人

职位地址：苏州-常熟江苏省常熟市碧溪街道通联路18-1号 18-1, Tonglian Road, Bixi Subdistrict, Changshu City, Jiangsu Province

注册资本： 231795.20万人民币

经营范围：受瑞士诺华公司（NOVARTIS AG）及其所投资的中国公司委托，向其提供资金运作和财务管理、运营管理、承接诺华中国境内公司内部的共享服务及境外公司的服务外包、员工培训与管理服务；药品的研究和开发，并提供相关的技术咨询和服务，在浦东新区金科路4218号1、2、3、4和7幢从事自有房屋租赁服务。【依法须经批准的项目，经相关部门批准后方可开展经营活动】

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