1.Supervise operators to produce qualified pharmaceutical products in accordance with GMP, EHS and other regulatory regulations, accomplish the production assignment on time; Responsible for work on documentations(including SOP, batch record and data analysis etc); Give training to workers; Timely take correct actions to the abnormal issues in production 管理一线操作人员按照GMP、EHS及其它法规的要求，生产出符合质量要求的药品，按时完成生产任务；负责文件方面的工作包括SOP、批记录和数据分析等；对下属员工进行培训；及时、正确处理生产过程中发生的异常情况
Experiences Desired 相关工作经验要求
1.3 years or above experience of production management within the Pharmaceutical or Food Industry. 三年以上制药、食品行业生产管理方面的经验
Educational/Knowledge Desired (including professional qualifications & language proficiency) 必要的学历和专业资格，含语言能力 1.College graduate or above, major in Pharmacy, Chemistry or Management
大专或以上学历，药剂、化学或管理类相关专业 2.Have an excellent ability to listen, speak, read and write in both English and Chinese 具有良好的中英文听说读写能力
Skills & Ability Desired 必要的技能和能力 1.Ability of leadership on people and production management
The role is to be a trusted, agile partner who engages in influential dialogue and delivers timely, high impact data and insights that advance the science or accelerate access, shape medical practice and drive appropriate adoption of BMS medicines. The role is has a high level of independence, experience as a coach/mentor, and may act as medical representatives, as appropriate. While the role is still a customer-focused role, they may spend additional time in cross functional matrix collaborations, depending on local product lifecycle. Below is the role of the Medical Lead Hong Kong.
Country Medical Lead accountable for leading the Hong Kong medical team and for providing a comprehensive and proactive medical service for supporting R&D, medical information, pharmacovigilance, market access and all relevant business functions as appropriate. The Medical Lead Hong Kong will be a key member of the Pac Rim Cluster medical team supporting the Medical Lead Pac Rim, as well as the communication between the WWMTs and the Hong Kong medical team. The Medical Lead Hong Kong will also be a member of the Hong Kong Operating Committee
1. External Environment and Customer Focus
Role model in developing and maintaining peer-to-peer relationships and close contacts with Thought Leaders, appropriate HCPs, and access stakeholders, within a given geography to answer unsolicited product and HEOR related questions.
Master proficiency in available scientific resources and presentations. Effectively present information to HCPs, as appropriate, ensuring medical accuracy and compliance with local procedures, ethical and legal guidelines and directives.
Actively profile the medical and competitive landscape to effectively evolve planning at the market level within the medical team and matrix leadership teams, as appropriate.
Collect, analyze and present meaningful medical insights back to the medical and commercial organizations at brand team meetings to be actioned in support of the strategy development.
2. Design and Deliver the Medical Plan
Provide strategic input into the development of Brand plans and act as a role model in developing and executing the medical plan and related TL interaction plans. May contribute to regional / Worldwide medical plans, as appropriate.
Deliver scientifically meaningful medical programs proposals and ensure flawless execution of medical activities to support overarching medical plan execution.
Discuss and deliver Health Economics and Outcomes Research (HEOR) evidence based information reactively (ie, to government agencies, healthcare organizations, and payers), as appropriate.
3. Provide Medical Support
Supervise a field-based medical team with ensuring full external focus and priority on high-quality customer interactions.
Lead cross functional collaboration within matrix teams to ensure appropriate embedding of the medical perspective and aligned focus in key critical execution to achieve overall medical strategies and objectives.
Represent medical as a key reference point for internal stakeholders and a regional reference for other SA’s (mentor or coach); demonstrate the ability to train SA’s by supporting with role play simulations and/or co-visits, while acting as a role model.
Facilitate continuous improvement towards higher quality work and promote innovation within the local team.
Lead the development of the medical / scientific sections of pricing and reimbursement files, if appropriate.
4. Support Clinical Trial Activities
Identify local needs and provide input into NRDG strategy development, as appropriate.
Contribute to the “early prioritization” of development programs for the country by collating and integrating data on disease incidence / prevalence, treatment patterns, unmet medical needs and interest from the scientific community, as appropriate; Serve as point of reference for compounds in early development.
Act as medical study director / study monitor and complete the designated training for these roles, if appropriate and in agreement with local medical management.
Actively track study performance and contribute with insights and solutions.
Ensure that BMS Pharmacovigilance procedural documents are understood and applied by Investigators of local studies, and alert appropriate BMS personnel to any identified Adverse Events.
Medical doctor (physician), PharmD or PhD, with experience in a specific Disease Area or with a broad medical background Or Science graduate with substantial and relevant pharmaceutical experience
Extensive knowledge and/or experience of healthcare and access environments
Extensive expertise in and knowledge of the medical organization
Excellent performance within the last 2 years;
Therapeutic Area point of reference for internal/external stakeholders with superior disease Area knowledge and understanding scientific publications
Expert knowledge of a scientific or clinical area
Expert knowledge of relevant BMS products highly desirable.
Expert of clinical trial design and process
Demonstrated track record of the above
Training others and working as a mentor
Market / Regional / WW initiative contribution which generated value to the organization
According to the supervisor's daily working arrangements, follow the compliance requirements from GMP, EHS and other regulatory regulations, in accordance with related SOPs, produce qualified pharmaceutical products and accomplish the production assignment on time.根据生产主管日常工作安排，在符合GMP、EHS及其它法规的要求下，按照岗位标准操作规程，生产出符合质量要求的药品，按时完成生产任务。
Have working experience in production line related with Food or Pharmaceutical industry etc.
Technical school education or above
Knowledge of GMP is necessary, knowledge in basic English and basic computer skills
Asset automatic control system management, set and fulfill system lifecycle acceptance, backup and disaster recovery procedure. 管理生产设备自动化控制系统，完善、制定和执行系统整个生命周期的验收、备份和灾难恢复等流程。Resolve automatic control failure occur in daily operation. Act root cause analysis to the failure, and set up the proactive method to increase reliability. 解决生产过程中自动化控制系统发生的故障。并对设备自动化系统发生的故障进行分析，制定相应的预防措施来提高可靠性。According to requirement, modify control problem to suit law, regulation and production demand. 按需求优化现有自动化控制程序，已符合相应的法律法规和生产要求。Support project implementation. 支持各类项目开张。Work with maintenance team to set maintenance procedure and regulation to meet site reliability target. 和维修团队一起制定维修流程和规范，以保证达到工厂可靠性目标Ensures EHS and GMP practices and regulations are considered in all maintenance activities. 确保所有维修活动符合EHS和GMP规范。
Responsibilities: · Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites. Documents the visit and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators. · Recommends sites for consideration in future studies, as needed. Expedites the pre-study and study initiation processes including the conduct of pre-study evaluation and site initiation visits. Conducts initiation visits in collaboration with clinical site managers, field medical and/or protocol managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements. · Ensure study milesones and recruitment target achieved. Reviews site activities and quality through on-site visits in addition to remote management capabilities. Monitors study sites following the monitoring plan, BMS SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory. · Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities. · Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented. · Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. · Facilitates the Regulatory Compliance audit process, as needed. · Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner. · Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues, etc.).
Qualifications: · Bachelor’s degree in Pharmacy or relevant, at least 1-2 years of site monitoring experience . · Ability to manage multiple protocols across multiple therapeutic area, knowledge of clinical trial conduct including HA requirements and ICH GCP. · Good command of English communication, Excellent communication skills (written and verbal) & Excellent organization skills. · Reviews site activities through on site/ off site monitoring and contact to monitor study sites as per monitoring plan and the applicable BMS SOPs, to ensure data integrity /patient safety, study milestones/recruitment achieved and maintain strong site relationship.
1. Perform the routine inspections on the key steps in production area according to the SOPs, to ensure the routine operations comply with the requirements of SOP, GMP and MLS/PLS 按SOP要求对生产区域各工段进行工作，确保日常操作符合SOP 、GMP及MLS/PLS的要求 2. Sample the intermediate bulk or finished product according to Sampling Manual, and send it to QC. Enter the sample data in LIMS system. 按取样手册要求对产品中间体/成品进行取样，并及时送样在LIMS系统中输入样品数据 3. Fully investigate the quality event to find the root cause and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA. 对质量事件进行调查以确认事件根源，并完成调查报告采取适当的整改措施（CAPA）并跟踪 其及时完成 4. Investigate customer complaint and fulfill the investigation report. Take the proper corrective actions & preventive actions (CAPA) and follow-up the timely completion of CAPA. 对顾客抱怨进行调查，并完成调查报告采取适当的整改措施（CAPA）并跟踪其及时完成 5. Participate and monitor the validation of the manufacture process and facilities cleaning, and sample the products by the requirement of validation 参与产品生产过程及设备清洁验证，监督验证过程并按验证要求取样 6. Establish the relevant SOPs according to the requirements of cGMP and actual operations, to ensure the operations comply with SOPs. 根据GMP要求和实际日常工作情况制定相关SOP，确保操作与SOP一致 7. Control the status of the raw materials and intermediate bulks used for production. And inquire, re-check and change the status of some raw materials and packaging materials in SAP system 生产过程中物料、中间体的状态控制并在SAP系统中查 询 、核对及修改物 料 状 态 8. Perform the sampling of environment and water system in production area according to the sampling method and frequency in SOP. 按照SOP规定的操作方法及取样频率对生产区域的环境及水系统进行取样 9. Check PO and BOM to make sure the veracity 检查生产指令单及BOM以确保其准确无误 10. Complete other assignments given by the superior 完成领导交办的其它任务
1.Implement monthly and annual site supply planning in ERP (SAP) system based on market replenishment plan, to ensure the market supply is fully satisfied in both quantity and accuracy. 在工厂的ERP（SAP) 系统中根据补货计划进行相关的月度和年度生产计划安排，以保证按时按量满足市场所需的补货计划 2.Based on site actual production capacity, manage and adjust plans as required to comply with the required market demand, while also meets expected site inventory levels 根据工厂实际生产情况按需调整分月计划从而确保生产量能够满足市场需要，同时也能达到工厂预期的库存目标 3.Based on monthly site production plan, run and get related raw and package material requirement plan to ensure the delivery of the materials can satisfy the need of production. 根据工厂分月生产计划的安排，对所需的原辅料和包装材料制定相应的物料计划以确保物料到货时间能满足生产的需要 4.Run exceptional reports to identify material exceptions and communicate with Procurement, QC Planner, Production department, etc. to solve the problems and ensure the achievement of production plans. 运行异常情况报告从而确定材料异常情况，并联系采购部，质量部门计划员, 生产部等解决问题并保证生产计划得以完成 5.Manage site supply planning part of launch, discontinuation of products and artworks changes. 管理产品上市，停产和画稿变化中的生产计划相关内容 6.Set up and manage the safety stock of raw materials, excipients and packaging materials. Balance the relationship between ontime production vs. cash flow. Use appropriate inventory level and accurate inventroy management to ensure the achievement of production plan. 对于所需原辅料和包装材料的安全库存进行设置和管理，平衡生产及时性和资金占用性之间的关系，用合理的库存设置和精准 的库存管理确保生产计划的完成 7.Predict potential risks in site production plan, communicate to Replenishment Planner timely to avoid any delay of supply or backorder. If potential supply risks are highly possible, report to Supply Chain Director immediately together with Replenishment Planner. 对于工厂生产计划中可能发生的问题和可能的风险作出预判，并及时与市场计划经理沟通以尽可能避免延迟交货或缺货。如确实预见到供货风险需立即汇同市场计划经理向供应链总监汇报。 8.Provide analysis and justifications on production plan related performance indications, including backorder, potential backorder, inventroy level and potential write-off, etc. 对于工厂生产计划相关的绩效指标提供分析和解释，包括缺货报告、预计缺货报告、库存状态、潜在报废等。 9.Complete material requirement planning and related analysis during annual budget process. 完成年度预算相关的生产量和物料需求量的预估和分析 10.Fully responsible for SASS Site Statistics reports management, including collection and consolidating required data from related departments, consolidate and report online based on the timeline required by Statistics Bureau or Industrial Information Bureau. Details including but not limited to monthly reports, quarterly reports and annual reports. 负责SASS工厂的统计和上报工作，包括从相关部门收集统计所需的数据，根据统计局和工信部的时间要求进行数据的汇总和网上申报，具体包括月度统计报表，季度统计报表，年报表等。 11.Be the primary contact and receiving person from SASS site for daily supervision from Statistics Bureau, coordinate internal departments to receive and manage related inspection and investigation requirements from the government. 作为工厂与统计局的对接人员协调和处理统计局的各种日常监管，协调工厂内部部门接待统计局的检查和调研等。 12.Collect and file BMS Supply Chain related guidelines and operation processes. Complete SAP SC related training and testing 收集和整理BMS供应链总部相关的指导文件和操作流程, 根据需要完成SAP系统供应链相关的培训和测试。 13.Complete other assignments given by superior. 完成领导其他交办任务