- Provide strategic and managerial leadership of the Quality units at BeiGene's current manufacturing sites in Guangzhou, Suzhou, Beijing (China) and Hopewell (New Jersey, USA)
- Ensure MAH responsibilities in China are fulfilled in according with NMPA GMPs and other applicable regulations
- Lead Quality strategy for future manufacturing network planning and capacity utilization in Global Tech Ops
- Develop the capabilities of high performing Quality units at BeiGene sites, to meet global GMP expectations for all markets to which they are supplying
- Ensure leadership, guidance and development opportunities for direct reports
- In collaboration with Global Quality, develop and maintain quality standards and strategies to support the company's ambition of an expansive manufacturing and distribution network
- Responsible for the release (or rejection) of all phases of raw materials and products (clinical and commercial) manufactured internally at BeiGene
- Responsible for the implementation, management and continuous improvement of quality systems at BeiGene sites, including the dissemination of best practices via the global network of sites
- Ensure that BeiGene's network of manufacturing sites is inspection ready at all times
- In collaboration with Global Quality, Regulatory Affairs, and local QPs, act as the primary interface with all health authorities (especially NMPA) on quality topics during health authority site inspections
- In collaboration with BeiGene manufacturing site GMs, establish and maintain a Culture of Quality
- Partner with CMC and manufacturing teams to establish clear, consistent and efficient processes and execution capability, enabling scaling of the business, while maintaining or improving quality standards and cGMP compliance
- In collaboration with Global Quality QMS, establish and monitor metrics / key performance indicators for the quality system
- Provide periodic reporting to Quality Management on the performance of the Quality System along with appropriate action plans to address needs
- In collaboration with the Head of External Quality, responsible for conducting and publishing the Annual Product Review for BeiGene products
- Fulfill the role of Management Representative for the BeiGene China site network quality systems
- In collaboration with Global Quality QMS, ensure appropriate training and education is delivered to manufacturing site personnel and monitor effectiveness
- Other duties as assigned
- This position requires strong cross-cultural and international leadership experience to ensure high performance management, coaching and mentoring of BeiGene staff.
- Strong PC literacy
- Extensive experience with GxP QMS platforms, e.g. Veeva
- Minimum of 15 yrs experience in GMP environment with at least 10 yrs Quality management experience in biological and small molecule product manufacturing
- Prior experience interacting with health authorities during pre-approval and routine site inspections is highly desirable
- Experience with manufacturing and distribution of clinical and commercial products preferable
- Experience with global multi-national companies is highly desired, especially where long-term overseas assignments were included
- Excellent verbal and written communication skills
- Cultural dexterity in work environments
- Ability to effectively collaborate in a high-paced dynamic environment
- Fluent or native Mandarin Chinese
- Fluent in English
- Up to 50% within Greater China
- Up to 20% globally
- 团队协作
- 提供并征求坦诚及可行的反馈
- 自我认知
- 兼容并蓄
- 积极主动
- 开拓精神
- 持续学习
- 拥抱变化
- 结果导向
- 分析性思维/数据分析
- 卓越财务
- 清晰沟通
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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Head of Internal Supply Quality - Shanghai, 中国 - BeiGene
描述
Job Description:
Overall responsible for Quality oversight and cGMP activities at BeiGene's internal manufacturing sites, including manufacturing, testing and release of clinical and commercial products, including small molecule, large molecule, combination products and all future products produced internally at BeiGene. The Head of Internal Quality shall provide leadership and strategic direction for Quality units at current and future BeiGene manufacturing sites to ensure compliance with Global Quality policy and standards and aligned with corporate business objectives. They must possess a strong working knowledge of global regulatory expectations, manufacturing technologies and pharmaceutical best practices as well as operational excellence and continuous improvement principles. A deep understanding of Chinese Manufacturing Authorization Holder (MAH) responsibilities is crucial.
This position must be China based andnd we welcome candidates with a global background and perspective wanting to return or move to China
Essential Functions of the job:
Qualification Required:
Supervisory Responsibilities:
Computer Skills:
Other Qualifications:
Travel:
百济神州全球胜任力
当我们通过以下十二项全球胜任力,展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时,我们就能帮助全世界更多患者获得更多负担得起的药品。
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
求职者隐私申明:
百济神州致力于尊重和保护求职者的个人信息权利,并承诺依据合法、正当、必要和诚信的原则处理求职者的个人信息(包括个人敏感信息,如有)。更多详情,敬请查阅百济神州《求职者隐私政策》。
由于百济神州在全球范围内开展业务,我们需要基于集团人力资源统筹管理的合理业务目的而向百济神州关联公司(BeiGene Ltd.)提供求职者的简历及求职信息,求职者的信息将被存储在位于中国境外(目前位于美国)的Workday数据库。如需行使中国法律规定的各项个人信息权利,可通过联系BeiGene Ltd.
Due to the reasonable business need for human resource management as a result of BeiGene's global operation, job applicants' resume and job application relevant information may be provided to the BeiGene affiliate (BeiGene Ltd.), and the aforementioned data will be stored in Workday (currently located in the U.S.). If the job applicant wishes to exercise his/ her personal information rights provided under PRC laws, he/ she may contact BeiGene Ltd. via
如您主动向我们提供您的个人信息,则视为您已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。如您主动向我们提供其他求职者的个人信息,则视为您确认相关人员已经理解并接受百济神州《求职者隐私政策》以及相关个人信息处理规则(尤其是向中国境外提供个人信息)。
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to BeiGene's Job
