About The Role

负责口服固体制剂产品从早期临床开发、后期临床试验直至NDA申报全过程的质量保证（QA）监督与管理。 • 确保技术转移、工艺放大、临床试验用药品（IMP）生产以及注册相关活动全面符合适用的GMP、临床GMP及数据完整性要求。 • 对生产和质量控制活动实施QA监督，确保整个临床开发阶段持续符合GMP要求。 • 确保所有与临床试验产品相关的QA活动符合全球法规要求及公司内部质量标准。 • 支持建立、维护并持续改进现场质量管理体系（QMS），确保与全球QA战略保持一致。 • 审核并批准GMP及质量相关文件，包括技术转移资料包、工艺开发文件、验证策略及变更控制记录，确保符合产品不同开发阶段的合规要求。 • 主导或支持临床产品生产及检测过程中产生的质量事件调查与解决，包括偏差、OOS/OOT结果、投诉及CAPA等。 • 与CMC及跨职能团队紧密合作，支持临床开发活动、临床供应准备以及法规注册申报（IND/CTA及NDA）。 • 负责临床用原辅料、包装材料、中间产品及成品药的QA放行。 • 监督产品全生命周期质量活动，包括产品投诉、召回、产品年度回顾以及产品档案（PSF）的维护。 • 参与并支持外部审计、药监机构检查以及临床开发和注册阶段的法规沟通活动。 • 参与内部GMP自检，确保后续跟进及时完成并采取有效纠正整改措施。 Education: Bachelor or above degree in Pharmacy, Chemistry, or related. Master degree is preferred. Experience: At least 8 years' experience in pharmaceutical industry, at least 5 years’ GMP experience; MNC/big pharma company working experience is preferred. Technical skill: Rich experience in GxP area of Quality and compliance management environment. Familiar with the requirements of China GMP, EU GMP and FDA cGMP, familiar with the Industry Guidelines, such as ICH, ISPE, etc. Familiar with process and quality control of oral solid products. Experience Quality Management of Investigational Medicinal Product. Familiar with CMC development and registration process of new drug during product lifecycle. Soft skill: Continuously invest time and effort to gain new skills and knowledge required to succeed in the work. Good communication skill. Show strong willingness to work closely with peers within and outside the team toward a common goal. Leadership skill, provide clear direction and define priorities for the team and win the commitment of team members. Language: Fluent spoken English 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 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。 BeOne 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 BeOne’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 BeOne Job Applicant Privacy Policy (BeOne 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 BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.

This is an external listing. JobSpring does not represent or verify the employer. Report this listing

临床产品质量保证经理

About The Role