QA FL

职位亮点Position highlightsl前沿领域：深度参与ADC药物的生产与检测全流程，接触行业顶尖技术平台。Cutting-edge field: Deeply involved in the full production and testing workflows of ADC (antibody-drug conjugate) drugs, gaining exposure to industry-leading technology platforms.l全周期视野：覆盖从临床早期研发到商业化生产的全阶段项目，能够积累并掌握完整的全生命周期质量管理体系实战经验。Full-cycle perspective: Covers projects at all stages from early clinical R&D to commercial manufacturing, enabling accumulation and mastery of practical experience in end-to-end lifecycle quality management systems.l全权负责：从GMP生产到注册申报，拥有完整的项目质量管理视野。 Full ownership: Responsible for everything from GMP production to regulatory submissions, with a comprehensive view of project quality management.l核心枢纽：作为连接客户与内部生产的核心接口，直接引导项目质量策略的落地。Central hub: Acts as the primary interface between clients and internal manufacturing, directly driving the implementation of project quality strategies.岗位职责 Job descriptionADC全流程质量闭环管理 ADC end-to-end closed-loop quality managementl负责与客户进行质量协议的谈判，起草与定稿，明确双方在GMP生产/检测及放行环节的质量责任与标准。Responsible for negotiating, drafting, and finalizing quality agreements with customers, clarifying both parties’ quality responsibilities and standards for GMP production, testing, and product release.lADC药物从原液到制剂生产及后续检测环节的质量问题联络人: 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 liaison for ADC products from bulk drug substance to formulation production and subsequent testing: responsible for systematic tracking and recording of all quality issues during GMP production, serving as the primary interface to communicate issue progress to customers, and coordinating internal resources to ensure issues are resolved promptly and effectively, thus closing the loop.l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。Track the progress of GMP production batches and coordinate resources to ensure on-time completion. Support communication to resolve quality and technical issues arising during production. After batch completion, ensure timely and complete delivery of batch production records and all related quality documentation in accordance with customer and regulatory requirements.l负责主导年度产品质量回顾的编制与审核。系统性汇总并分析年度生产数据、质量趋势及稳定性考察结果，识别潜在工艺风险，推动质量体系的持续改进与合规优化。Lead the preparation and review of the annual Product Quality Review. Systematically compile and analyze annual production data, quality trends, and stability study results, identify potential process risks, and drive continuous improvement and compliance optimization of the quality system.客户接口与项目质量主导 Client interface and project quality leadershipl作为面向客户的首要质量联络人，建立并维护高效的沟通机制。准确解读客户的质量体系要求与定制化需求，并将其转化为内部可执行的操作标准。Act as the primary quality contact for clients, establishing and maintaining efficient communication mechanisms. Accurately interpret clients’ quality system requirements and customized needs, and translate them into internally executable operating standards.l定期召开质量会议，向客户透明化展示问题处理进度，确保所有质量反馈形成有效闭环。Convene regular quality meetings to transparently present issue resolution progress to clients, ensuring all quality feedback is closed effectively.l支持客户和官方审计，包括提供项目背景资料、现场陪同审计及专业答疑，展现团队专业度，推动审计顺利通过。Support client and regulatory audits, including providing project background materials, accompanying audits on site, and responding to technical questions, demonstrating the team’s professionalism and facilitating successful audit outcomes.法规注册与体系优化 Regulatory registration and system optimizationl依据药品上市许可持有人及生物制品许可申请等法规标准，协同团队整理并审核注册申报所需的质量资料包，确保数据的准确性与提交的及时性。In line with regulatory standards such as Marketing Authorization Holder requirements and biological product license applications, collaborate with the team to compile and review the quality dossier required for regulatory submissions, ensuring data accuracy and timely submission.l充当内部流程优化的催化剂，基于客户反馈与法规动态，主导或参与跨部门质量流程的改进项目，提升整体运营效率。Act as a catalyst for internal process optimization; based on client feedback and regulatory developments, lead or participate in cross‑functional quality process improvement projects to enhance overall operational efficiency.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