长沙 [切换城市] 长沙招聘长沙生物/制药/医疗器械招聘长沙医药技术研发管理人员招聘

Clinical Operations Quality Manager

万全医药集团

  • 公司规模:1000-5000人
  • 公司性质:合资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2012-11-09
  • 工作地点:北京-海淀区
  • 招聘人数:1
  • 职位类别:医药技术研发管理人员  

职位描述

Job Responsibilities:
? Implement and deliver the agreed upon National Quality Control plan which includes risk management, to assist Clinical Operations to deliver a better compliance with relevant ICH, GCP, country regulations and guidelines.
? In addition to the national plan, contribute to the development of and will be responsible for implementation and delivery of specific regional/local initiatives as defined and agreed upon with Regional Quality Management.
? Contribute to the development and implementation of a Regional/Country Quality Control Plan and Risk Management Program adapted to local needs and monitor implementation and delivery.
? Provide advice and support to LOCAL Clinical Operations, including Project Manages, Line Managers, LOCAL Learning and Development trainers, and Quality Assurance on all aspects of compliance, SOP development and customer requirements and work in close cooperation with operational teams to review, escalate and manage the quality issues.
? Assist in corrective action plans preparation and implementation and audits for regulatory inspections and partnering with QA in case of suspicion of fraud or misconduct.
? Ensure adequate communication with the Local Heads of Clinical Operations to get them engaged in the deployment of the strategy.
? Act as the conduit between the local offices within the region/country and Quality Assurance Services, attending meetings/teleconferences as needed to exchange performance related data and information on quality issues and initiatives.
? Inform AD Clinical Operations Quality Management, Head of Clinical Operations in the country and Quality Assurance Services of significant quality issues as they arise, in accordance with appropriate operating procedures/work instructions.
? Prepare periodic reports to AD Clinical Operations Quality Management on quality related matters, risk assessments and local quality improvement initiatives.
? Assume a customer facing role in the country for quality related issues. Act as the primary contact for Quality Assurance for local / country matters.
? Act as the primary contact for Quality Assurance for local / country matters.?
Qualifications

Requirements:?
? Degree or equivalent in Life Sciences or Health Care with minimum 6 years' relevant Clinical Research and/or Clinical Quality management experience in the pharmaceutical industry including at least 2 years experience in a role equivalent to Clinical Team Lead.
? Sound working knowledge of medical terminology, clinical monitoring procedures (SOPs), GCP, FDA regulation and quality performance initiatives and processes.?
? Knowledge of National and International Regulations and Drug Development process.
? Knowledge of CRO or Pharmaceutical industry operations.
? Sound knowledge of Clinical Management applications and high proficiency in Microsoft Word / Excel / Powerpoint / Outlook.
? Excellent, interpersonal, communication and organizational skills.
? High motivation with drive, ambition, persistence, energy and confidence.
? Demonstrated ability to lead a team and work in a matrix environment.
? Able to travel when required.

公司介绍

万全是一家中国领先研发驱动数字生态的跨国医药服务组织。一家互联网垂直整合下4O平台(PDO-CRO-CDMO-ADPO ),旗下两家关联上市公司。
·德众万全PDS :载誉15年,中国新药研发批准排名最前列,获***新药四百多件,申请专利千项;
·阳光万全CRSO:让世界为中国临床研究喝彩,参与30多项国家973,十二十三五国家重大创新和参与获得国家创新一等奖;
·万特制造云CDMO:六家制造基地通过WHO等国际认证;
·万德玛ADPO: 中国新药沃尔玛,科研临床推广和互联营销的推广的先行者!

创新的万全之技 健康的万全之策
——我们曾经骄傲的宣称我们是中国制药的发动机,上千专利,15年研发领先,未来产品最多拥有者。填补国内多项空白技术:靶向给药,脂质体给药,口腔崩解剂都是国内***;我们也曾经如此刚到光荣,全国高端临床研究,国家十二五十三五重大专项有我们的组织,国家科技进步奖阳光万全是最多的获奖和引领者。

健康的万全之策
——不忘初心万全在许多重大疾病治疗影响非凡
1. 喜恩万全:心脑双喜,这个脑科学领域最响亮的名字在国家脑科学战略中提出六大组方。《喜恩formula1:StartD解忧组方》;《喜恩幸福组方曲优+乐孚亭》《喜恩卒中防治7组方》《喜恩解忧防治卒中》提出治疗卒中的第四干预治疗方案,《喜恩癫痫防治领域》,《喜恩抗痴联合组方》
2.万全在中国***致死率的疾病卒中方面。
3. 万全在全球***流行疾病吸烟成瘾疾病方面,健康中国戒烟国策,吸烟是致命的***流行疾病。悦亭不仅是全球戒烟处方领导者。
4 .本世纪最难攻克和最昂贵的疾病要属老年痴呆 。
5 .过敏顽症之世纪流行,中国儿童几乎超过每三个就有一个过敏。拜敏Bye,拜拜过敏全球抗敏领导者。
6.卡地万全健康心脏五大处方,卡地健康心脏(亚洲)研究院。
7.健寿万全抗痴衰研究中心。这个中心有个宏伟的计划,就是重新筛选改变对现在药品和医疗的认知,让人类可以健康不受疾病困扰(健寿)地多活数十年
8..渐冻人ASL这个世界五大绝症,万全不仅四千人为爱捐款,同时万全罕见病渐冻人中心的万全力太成为救命的***药。

联系方式

  • Email:vdmhra3@venturepharm.net
  • 公司地址:北京市中关村生命科学园 28号博达大厦 (邮编:100089)