Manager, Clinical Supply Chain

General Description: The Associate Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future. Essential Functions: • Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC). • Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines. • With minimal supervision, create supply and inventory plans and develop production schedules for clinical trial materials. • Monitor schedule adherence of production schedules and make course corrections if needed. • Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability. • Monitor daily activities for FG label & pack CMOs and distribution vendors with internal stakeholders. • Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure. • Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s). • May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs. • With minimal guidance, support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system. • Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses. • With minimal supervision, develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans. • Supports functional projects and process improvements related to drug supply. • Assist in the creation or revision of process documents such as Standard Operating Procedures. • Additional responsibilities as required. • Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management Competencies: • Demonstrates knowledge of global clinical trials and the drug development process. • Experience in vendor oversight and managing external partnerships and relations. • Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP). • Experience in deviation investigation and CAPA implementation. • Knowledge of IRT system setup and functionality and proficiency with Excel modeling. • Strong analytical, problem solving, and communication skills. • Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams. • Experience in deviation investigation and CAPA implementation. Education Required: • Bachelor or Master Degree in Business Administration, Operations Management, or similar education required. • 3-5+ years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry. 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. 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