QA Manager（小分子）
Summary
Quality Assurance Manager overseeing cGMP compliance for small molecule clinical trial medicine (CTM) manufacturing, testing, and release at BeiGene's Beijing quality operations. Acts as QA single point of contact for small molecule projects, handling deviations, CAPA, change control, SOPs, and compliance with NMPA, FDA, EMA, ICH, and pharmacopeia standards.
General Description:
In this role, will oversee the Small Molecule CTM (Clinical Trial Medicine) manufacturing related cGMP activities under Beijing quality operations, include manufacturing, testing and release of CTM for Beijing Med-Chemistry Research and Development department which are aligned with BeiGene Global Quality and corporate business objectives.
The primary responsibility as QA will focus on manufacturing and QC compliance related activities and QEs.
This role will provide QA support to assigned Small Molecule projects as SPOC from Quality perspective.
This individual must possess strong working knowledge of QA/QC/manufacture, in-depth understanding of local and international HA regulations, such as NMPA , US FDA, EMA, WHO, PIC/s GMPs, and ICH regulations etc.; in-depth understanding of analytical technologies, familiar with international pharmacopeia requirements, such as USP, EP, JP, ChP. etc.
Essential Functions of the job:
⬧ Oversight CTM Manufacture/testing/release, ensure compliance with the cGMP and or ICH or other related regulation requirements with phase appropriate when applicable.
⬧ Responsible as project QA to provide QA support to assigned Small Molecule projects as single point of contact from Quality perspective.
⬧ Responsible for manufacturing workshop, warehouse, facility and EHS oversight, ensure complied with SOP and related regulations.
⬧ Responsible for manufacturing and analytical testing related Change Control, Deviation, CAPA, Complaint, recall and other quality event oversight, ensure complied with SOP and related regulations.
⬧ Responsible for QA, manufacturing, warehouse, facility and EHS SOPs review, ensure compliance with related regulations and guidelines.
⬧ Draft QA SOPs or/and coordinate the drafting, review or/and approval of SOPs and documents based on the authorization.
⬧ To ensure that the appropriate method validations/verifications are done.
⬧ Compose/coordinate quality compliance required reports
⬧ Other duties as assigned by superior.
Computer Skills:
Proficient in computer skills including Outlook, Word, Excel, and PowerPoint, etc.
Other Qualifications:
⬧ 5 years of experience in Quality department, total more than 7 years of Quality operations experiences in pharmaceutical industry is preferred.
⬧ Good interpersonal communication skill
⬧ Capability of controlling and completing multiple issues with a clear sense of priority
⬧ Ability to analyze and resolve quality issues.
⬧ English: fluent in writing and speaking.
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。
●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
BeOne 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.
●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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