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Senior R&D QA Manager
25-45K/月上海市-上海/本科及以上/5-10年
任女士今天来过
第一三共（中国）投资有限公司
职位详情
岗位职责
Job Objective:
Implement and maintain the R＆D QA strategy(quality issue/CAPA management, GCP inspection readiness, SOP management, etc.) in DS China and improve the quality of the deliverables of the clinical operations.
Specific Responsibilities:
1. Implement and Maintain Global R&D Quality Assurance(QA) Strategy in DS China.
• Facilitation of the implementation of the QA strategy/plan in DS China in close alignment with the clinical operations.
• Advice and support of complying regulatory requirements and building them into the business process/procedures of clinical operations, if needed.
2. Manage Quality Issues (QIs) and CAPAs in DS China
• Oversight of key performance/quality indicators (KPIs/KQIs).
• Support of escalations of QIs and review of the QIs according to relevant SOPs.
• Facilitation of developing CAPA plan based on appropriate measures and executing CAPAs.
• Check of CAPA effectiveness with the appropriate indicators.
3. Facilitate GCP Inspection Management Activities in China
• Leadership of GCP inspection activities including the preparation and follow-up of the inspections in collaboration with internal and external stakeholders.
4. Manage Local R&D and QA SOP Life Cycle Management(LCM) and SOP Training in China
• LCM of local R&D SOPs in accordance with a relevant SOP
• Facilitation of SOP updates according changes of regulations and business circumstances
• Development and update of local QA procedures based on the activities.
• Execution of global/local SOP training and keeping the training records
5. Facilitate GCP Training and other Training related to R&D quality
• Conduct of GCP-trainings and other trainings related to quality activities to clinical operations.
6. Communicate with Global and Asia-Pacific QA Representatives
• Communication with global/Asia-Pacific representatives as a China R&D QA representative.
Experience and Qualifications:
1. Bachelor's Degree in Life Sciences, Pharmacy or Medicines required, master's Degree advanced degree in Life Sciences, Pharmacy or Medicines preferred.
2. Four or more years of involvement in the area of GCP Quality Assurance in GCP QMS.
3. Understanding of expectations of key Health Authorities in management of clinical trials, ICH/China GCP, QMS, current clinical operations, etc.
4. Profound understanding of the science of new drug development.
5. Fluent in Chinese and English language skill (written and verbal). Asia-Pacific languages (e.g., Japanese) other than those listed above, if at all possible.
6. Analytic and systematic approach with excellent problem-solving skills
7. Proactive and reliable work ability in international matrix teams
8. Ability to understand complex matters and work for continuous improvement
9. Abundant communication skills, especially respect and understanding of cultural diversity, even on a cross-cultural level
10. Flexible and adaptable
11. Excellent communication skills and intercultural sensitivity.
12. Effective project and time management skills and the ability to work under pressure
Implement and maintain the R＆D QA strategy(quality issue/CAPA management, GCP inspection readiness, SOP management, etc.) in DS China and improve the quality of the deliverables of the clinical operations.
Specific Responsibilities:
1. Implement and Maintain Global R&D Quality Assurance(QA) Strategy in DS China.
• Facilitation of the implementation of the QA strategy/plan in DS China in close alignment with the clinical operations.
• Advice and support of complying regulatory requirements and building them into the business process/procedures of clinical operations, if needed.
2. Manage Quality Issues (QIs) and CAPAs in DS China
• Oversight of key performance/quality indicators (KPIs/KQIs).
• Support of escalations of QIs and review of the QIs according to relevant SOPs.
• Facilitation of developing CAPA plan based on appropriate measures and executing CAPAs.
• Check of CAPA effectiveness with the appropriate indicators.
3. Facilitate GCP Inspection Management Activities in China
• Leadership of GCP inspection activities including the preparation and follow-up of the inspections in collaboration with internal and external stakeholders.
4. Manage Local R&D and QA SOP Life Cycle Management(LCM) and SOP Training in China
• LCM of local R&D SOPs in accordance with a relevant SOP
• Facilitation of SOP updates according changes of regulations and business circumstances
• Development and update of local QA procedures based on the activities.
• Execution of global/local SOP training and keeping the training records
5. Facilitate GCP Training and other Training related to R&D quality
• Conduct of GCP-trainings and other trainings related to quality activities to clinical operations.
6. Communicate with Global and Asia-Pacific QA Representatives
• Communication with global/Asia-Pacific representatives as a China R&D QA representative.
Experience and Qualifications:
1. Bachelor's Degree in Life Sciences, Pharmacy or Medicines required, master's Degree advanced degree in Life Sciences, Pharmacy or Medicines preferred.
2. Four or more years of involvement in the area of GCP Quality Assurance in GCP QMS.
3. Understanding of expectations of key Health Authorities in management of clinical trials, ICH/China GCP, QMS, current clinical operations, etc.
4. Profound understanding of the science of new drug development.
5. Fluent in Chinese and English language skill (written and verbal). Asia-Pacific languages (e.g., Japanese) other than those listed above, if at all possible.
6. Analytic and systematic approach with excellent problem-solving skills
7. Proactive and reliable work ability in international matrix teams
8. Ability to understand complex matters and work for continuous improvement
9. Abundant communication skills, especially respect and understanding of cultural diversity, even on a cross-cultural level
10. Flexible and adaptable
11. Excellent communication skills and intercultural sensitivity.
12. Effective project and time management skills and the ability to work under pressure
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公司信息
第一三共（中国）投资有限公司
- 上海
- 10000人以上
- 生物制药
- 外企
- 无
第一三共致力于通过运用我们全球一流的科学技术，创造新的模态与创新药物，以实现“为提高世界各地人们的生活质量做出贡献”的目标。除了目前的癌症与心血管疾病药物组合外，第一三共还专注于为癌症患者以及其他医疗需求未得到满足的疾病患者开发新疗法。凭借自身120多年的科学专业知识和覆盖20多个国家的业务范围，第一三共及其全球17,000名员工将秉承公司深厚的创新传统，努力实现我们的2030年愿景，成为“为社会可持续发展做出贡献的创新型全球医疗保健公司”。欲了解更多信息，请访问：www.daiichisankyo.com。
