丁香人才 > 职位招聘 >医药研发/制药生产招聘 >北京医药研发/制药生产招聘 >Quality & Compliance Manager招聘

Quality & Compliance Manager

西安杨森制药有限公司 2016-12-10发布 2017-02-02截止
  • 学历要求: 本科
  • 外语要求: 不限
  • 年龄要求: 不限
  • 专业要求: 不限
  • 工作年限: 五年以上
  • 月薪范围: 面议
  • 职位性质: 全职
  • 工作地点: 北京市
  • 职称要求: 不限
  • 招聘人数: 若干

职位描述

RESPONSIBILITIES

The Q &C Manager is responsible for performing activities within the assigned country/countries that(1) Support an integrated and comprehensive quality compliance approach for clinical trials in close collaboration with local and global quality functions, and (2) Support clinical trials are performed in compliance with local laws and regulations, industry standards and Johnson & Johnson / Janssen global processes and procedures.

QUALIFICATIONS

Education:
A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or equivalent is required. A minimum of 6 years of previous Pharmaceutical Industry experience is required, with at least 4-5 years of GCP experience within clinical research and development and/or quality assurance.

Related Experience:
• Knowledge of the overall drug development process
• Knowledge of business processes and practices (i.e., SOPs governing clinical research activities)
• Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
• Strong personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders; Strong networking and relationship building skills; Ability to create an open and inviting environment; Embraces generational differences; Exceptional written and verbal communications skills
• Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Ability to translate data into information and strategies into executable action plans improving the business.
• Ability to motivate professional colleagues and stakeholders
• Conflict resolution/management and negotiation skills
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks
• Experience of the key customers’ business processes and practices
• Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;
• Experience with regulatory submissions (NDA, BLA) is an asset;

General Skills:
• Problem solver
• Proactive strategic thinker
• Strong leader and collaborator
• Highly committed to quality
• Flexible and persistent
• Good conflict handling/negotiation skills
• Ability to independently plan, organize, co-ordinate, manage and execute assigned tasks
• Excellent communicator and presenter , with excellent interpersonal skills and diplomacy
• Excellent knowledge of English is required
• Proficient in Microsoft Office applications
• Able to create win-win situations with internal and external partners
• Stakeholder contacts are frequent and require excellent interpersonal skills and diplomacy
• Knowledge of the corporate structure and culture

Other Skills and Abilities: Requires little supervision and functions independently. Possess excellent written, oral communication, interpersonal skills, diplomacy, and presentation skills and outstanding customer service. C Manager has a dual reporting line into the GCO China Q&C head.

联系人: HR

地    址:北京市朝阳区建国路77号华贸中心写字楼

西安杨森制药有限公司成立于 1985 年,为美国强生公司在华最大的制药子公司。总部在北京,生产基地位于西安,在华员工近 3,000 人。我们一直秉承着对客户负责,对员工负责,对社会负责,对股东负责的信条,致力于引进和生产高质量的创新产品来满足不断增长的医药卫生需求。

美国强生公司创建于1886年,目前在全球60个国家建立了250多家分公司,是目前世界上最具综合性、业务分布范围最广的卫生保健产品的制造商和相关服务提供商,业务领域主要包括制药,医疗器械,和消费品。

西安杨森制药有限公司是美国强生公司在华最大的子公司,成立于1985年。公司管理中心位于北京,生产基地位于西安,在全国28个城市设有办事处,在华员工超过3000人。在过去的25年中,西安杨森保持持续稳定发展,成为了中国领先的合资制药企业。

西安杨森不断引进和生产多种创新的、高品质的药品,涉及九大领域近五十多种包装规格。其产品包括多种高质量的处方药,产品主要涉及胃肠病学、神经学、变态反应学、疼痛管理学、抗菌学、抗肿瘤和生物制剂等领域,西安杨森依托强生公司全球强大的研究开发体系 ...详情

单位概况

西安杨森制药有限公司
近两周应聘简历处理率:20%
制药/生物工程
医药企业 其他
规模不详
北京市朝阳区建国路77号华贸中心写字楼
查看完整地图

相似职位推荐

Copyright © 2007-2016 DXY All Reserved. 浙B2-20070219(含BBS) (浙)-经营性-2012-0008 浙卫网审[2014] 40号