General Description:
The role is responsible for overseeing end-to-end quality operational activities and programs related to commercial small molecule manufacturing at CMOs. Manages QA operational activities that support small molecule commercial products supply related cGMP activities including manufacturing, testing, packaging, release, and distribution of drug substances under applicable Regulations (US, EU, CN, etc.), ICH standards, and BeiGene processes and procedures.
Essential Functions of the job:
Author/Review standard operating procedures related to function and department and identify opportunities to streamline systems and processes.
Provide Quality support for cGMP external manufacturing operations at CMOs. Drive, lead and troubleshoot quality investigations at CMOs to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.02
Provide Quality guidance of cGMP external manufacturing operations (CMO). Advise on Quality Agreement content and support Quality Agreement implementation and updates.
Ensure CMOs are compliant for regulatory inspections and monitor progress of inspections. Perform on site quality visit (PIP) at request. Participate in quality audits that directly impact assigned projects.02
Review and approve CMO documents, like EBR/ CC, deviation and validations related.
Provide quality support for batch disposition of drug substance.
Work with departmental key stakeholders and internal staff to ensure processes and procedures remain in a compliant state for Small Molecule globally.
Review relevant GMP documents for compliance to company SOPs, quality systems and regulatory requirements.
Work with regulatory to author and review quality sections of regulatory submissions.
Other duties as assigned.02
Experience
Minimum 7 years of experience in Quality function of pharmaceuticals or biotechnology industry.
Computer Skills:02 02
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications: 020202
Understanding of Quality best practices, including familiarity with Quality Systems Regulations and GxPs,
Strong knowledge of Good Manufacturing Practices (e.g. EU, US, CN, PICS) and ICH guideline
Experienced with CMO management.02
Experienced in supporting projects towards process improvements.
Experienced in small molecule product quality, Drug substance quality experience is preferred. 020202020202
Ability to effectively manage time and progress tasks to meet timeline in a fast pace/dynamic environment.0202
Experienced working cross-department with CMC, regulatory and SC. 02Ability to work independently with scientific/technical personnel.
Effective oral and written communication skills.02
Oral and written proficiency in English required.02
Travel:
Occasionally, as required.
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
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.
●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
求职者隐私申明：
百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。
由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。
如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。
BeiGene is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity.
Due to the reasonable business need for human resource management as a result of BeiGene’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeiGene Job Applicant Privacy Policy (BeiGene official website - Privacy Policy - Job Applicant Privacy Policy).
If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.