QAFL (QA Function Lead)

职责/Responsibilities 质量问题追踪与客户沟通：负责GMP生产过程中所有质量问题的系统性追踪与记录，作为主要接口向客户沟通问题进展，并协调内部资源确保问题及时、有效解决，形成闭环。Quality Issue Tracking & Client Communication: Responsible for systematically tracking and documenting all quality issues arising during GMP production. Acts as the primary point of contact to communicate issue progress to the client, and coordinates internal resources to ensure timely and effective resolution, achieving issue closure.作为面向客户的主要质量联络人，负责日常沟通、关系维护及质量会议，准确理解、传达客户的质量体系要求与定制化需求，并推动内部协调以满足客户期望。Acts as the primary quality contact for clients, responsible for daily communication, relationship maintenance, and quality meetings. Accurately understands, communicates client’s quality system requirements and customized needs, and drives internal coordination to meet client expectations.客户审计支持与协调：在客户现场审计期间，为审计接待组提供客户背景资料与项目细节信息，协助沟通客户的具体质量要求，并参与现场陪同与答疑，支持审计活动顺利开展。Client Audit Support & Coordination: During client on-site audits, provides customer background information and project-specific details to the audit hosting team, assists in communicating specific client quality requirements, participates in on-site accompanying and Q&A sessions to support the smooth execution of audit activities.注册与法规资料管理：依据药品上市许可持有人及生物制品许可申请等相关法规要求，协调、整理、审核并确保项目相关的质量及注册资料包的完整性、准确性与及时提交。Regulatory & Documentation Management: In accordance with MAH (Marketing Authorization Holder), BLA (Biologics License Application), and other relevant regulatory requirements, coordinates, compiles, reviews, and ensures the completeness, accuracy, and timely submission of project-related quality and registration documentation packages.内部质量协同与流程优化：作为客户与内部团队的桥梁，及时响应并处理各方质量问询。通过跨部门会议协调内部资源，并基于客户反馈与法规动态，参与或主导相关质量流程的持续优化。Internal Quality Coordination & Process Optimization: Serves as a bridge between clients and internal teams, promptly responding to and addressing quality inquiries from all parties. Coordinates internal resources through cross-departmental meetings, and participates in or leads continuous optimization of relevant quality processes based on client feedback and regulatory updates.项目质量事件监督：负责监督并追踪与指定项目相关的偏差、变更控制及纠正与预防措施的执行进度与按时完成，确保其对项目质量与时间线的风险得到有效控制。Project Quality Event Oversight: Responsible for overseeing and tracking the progress and timely completion of deviations, change controls, and CAPA related to assigned projects, ensuring effective risk control to project quality and timelines.生产批次监督与记录交付：追踪GMP生产批次的进度，协调资源以确保按时完成生产。支持解决生产过程中出现的质量与技术问题沟通。在批次生产完成后，负责确保按照客户及法规要求，及时、完整地交付批次生产记录及所有相关的质量文件。Production Batch Monitoring & Record Delivery: Tracks the progress of GMP production batches and coordinates resources to ensure on-time completion. Supports communication and resolution of quality and technical issues arising during production. Upon batch completion, ensures the timely and complete delivery of batch production records and all related quality documents in accordance with client and regulatory requirements.其他职责：高效完成上级交办的其他任务。Other Duties: Efficiently completes other tasks assigned by supervisor. )资质要求/Qualifications: l化学、生物化学、生物学、药学等相关专业本科及本科以上学历。Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.l具有至少8年无菌药品生产及生物制药行业质量管理相关工作经验Possesses a minimum of 8 years of relevant work experience in quality management within aseptic pharmaceutical manufacturing and the biopharmaceutical industry.l熟悉国内外质量体系法规要求，如FDA/NMPA/欧盟法规及ICH等的要求Familiar with domestic and international regulations , e.g. FDA/NMPAS/EU GMP requirementsl熟悉无菌药品生产，熟悉质量体系Familiar with sterile pharmaceutical production and quality systeml良好的沟通协作能力Good communication and coordination skillsl良好的计算机办公技能Good computer skillsl良好的英文听说读写能力Perfect for good English listening, speaking, reading and writing skills