Clinical Operations Quality Lead (职位编号：226042)
勃林格殷格翰（中国）投资有限公司
- 公司规模：10000人以上
- 公司性质：外资（欧美）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2022-06-28
- 工作地点：上海-静安区
- 工作经验：5-7年经验
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床监查员
职位描述
Talent@Boehringer Ingelheim
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
As part of the TCM CO Quality team, be responsible for the quality initiatives in assigned area, this will include but not limited to:
-Implement global and local quality initiatives within the TCM CO
-Participate, support and actively contributes to continuous process improvements, knowledge management and training management within CO, when applicable
-Work closely with QM team to identify areas for quality improvement and discuss suggestions; support CO to plan /strategize quality initiatives and ensure implementation
Inspection Readiness:
-Work closely with CTMs within TCM CO to ensure inspection readiness plan is implemented for the assigned trials
-Familiarize with assigned trials for inspection readiness and lead/coordinate inspection readiness activities for the assigned trials
-Collate progress / status report of inspection readiness preparation activities for assigned trials and communicate such status / progress to stakeholders
-Support CTMs to ensure gaps identified during inspection readiness are appropriately addressed
-Collaborate with QM colleague to perform trend / GAP analysis for the trials that undergo inspection readiness, if required; and work with trial team to develop preventative measurements; to ensure preventative measurements are implemented
-Work with QM and other stakeholders in Medicine to support CTMs and CRAs during a site inspection or sponsor inspection; further more, coordinate certain activities on behalf of clinical operations, if required and appropriate.
Qualifications
-Minimum 5 years' experience in clinical operations, including at least 1 year quality relevant experience
-Project management experience or equivalence will be a plus
-Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical trials
-Strong Quality sense and proven records of high quality standard
-Good communication and organization skills
-Fluent in reading, writing and speaking English
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.
Job Responsibilities
As part of the TCM CO Quality team, be responsible for the quality initiatives in assigned area, this will include but not limited to:
-Implement global and local quality initiatives within the TCM CO
-Participate, support and actively contributes to continuous process improvements, knowledge management and training management within CO, when applicable
-Work closely with QM team to identify areas for quality improvement and discuss suggestions; support CO to plan /strategize quality initiatives and ensure implementation
Inspection Readiness:
-Work closely with CTMs within TCM CO to ensure inspection readiness plan is implemented for the assigned trials
-Familiarize with assigned trials for inspection readiness and lead/coordinate inspection readiness activities for the assigned trials
-Collate progress / status report of inspection readiness preparation activities for assigned trials and communicate such status / progress to stakeholders
-Support CTMs to ensure gaps identified during inspection readiness are appropriately addressed
-Collaborate with QM colleague to perform trend / GAP analysis for the trials that undergo inspection readiness, if required; and work with trial team to develop preventative measurements; to ensure preventative measurements are implemented
-Work with QM and other stakeholders in Medicine to support CTMs and CRAs during a site inspection or sponsor inspection; further more, coordinate certain activities on behalf of clinical operations, if required and appropriate.
Qualifications
-Minimum 5 years' experience in clinical operations, including at least 1 year quality relevant experience
-Project management experience or equivalence will be a plus
-Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical trials
-Strong Quality sense and proven records of high quality standard
-Good communication and organization skills
-Fluent in reading, writing and speaking English
职能类别：临床监查员
公司介绍
关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。
作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
让我们彼此成就，引领未来！
想获取更多信息，有以下方式：
1. 访问我们的官网,或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号：BI招聘
行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人，不要犹豫，马上申请吧!
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。
作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
让我们彼此成就，引领未来！
想获取更多信息，有以下方式：
1. 访问我们的官网,或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号：BI招聘
行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人，不要犹豫，马上申请吧!
联系方式
- Email：HRTalentAcquisition.CN@boehringer-ingelheim.com
- 公司地址：上海 (邮编：200041)
- 电话：13681838091