QA Associate Director

About the role

横琴质量保证（QA）负责人是一个领导岗位，负责监管本公司及其CDMO（合同开发与生产组织）的所有质量保证活动。该负责人将确保生物制品的生产、检测、放行及分销环节均符合监管要求、行业标准以及BioNTech内部的各项政策、标准和标准操作规程（SOP）。此外，该负责人将建立横琴质量管理体系（QMS）包括监管CDMO相关活动，对CDMO实施质量监督，推动持续改进举措，与跨职能团队协作，并确保产品质量与患者安全达到高标准。

The QA Head for Hengqin is a leadership role responsible for overseeing the quality assurance activities as MAH and at CDMO sites. The incumbent will ensure compliance with regulatory requirements, industry standards, and BioNTech internal policies, standards, and SOPs for the manufacturing, testing, release and distribution of biological products. The incumbent will establish the Hengqin QMS including the oversight of the CDMO activities and provide quality oversight of CDMOs, drive continuous improvement initiatives, work with cross-functional teams, and ensure high standards of product quality and patient safety.

Your contribution:

• 在“全球 OneQMS”和“中国共享质量管理体系（QMS）”框架下，建立针对横琴业务的特定质量管理体系。 Establish Hengqin specific QMS under global OneQMS and China shared QMS.
• 作为横琴质量保证负责人，审核和审批生产主批记录、产品和物料质量标准、检测方法、工艺规程及其他关键文件。负责横琴自有产品的 MAH 放行工作。 As Quality Assurance Head of Hengqin, review and approve master batch records, specifications of drug products and materials, test methods, process description and other critical documents; Also responsible for MAH product release for Hengqin owned products
• 参与所有横琴CDMO（包括合同生产商及检测实验室）的遴选、主导参与所有横琴CDMO资质确认及持续监控工作。通过项目实施计划（PIP）、审计及日常监控，确保 CDMO 遵守全球 GMP 法规（如 FDA、EMA、PMDA、ICH Q7、Q10 要求）及公司内部标准。 Participate in identification, assessment, and mitigation of GMP-related risks across the supply chain (end to end) for Hengqin products. Ensure that CDMOs comply with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards through PIP, audits and monitoring.
• 审核并批准审计报告、CAPA（纠正与预防措施）计划及后续行动，确保有效解决 CDMO 现场发生的不符合项及质量事件。 Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events occurred CDMO sites.
• 管理并监督 CDMO 现场涉及各项目的所有质量活动（包括偏差管理、变更控制、投诉处理、审计及产品质量回顾）。 Manage and oversee all quality activities (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review) at the CDMO sites.
• 提供GMP 合规性专家指导，并将重大质量事件、不符合项及合规问题上报至跨职能团队及高层管理人员。 Provide expert guidance on GMP compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.
• 与生产、分析方法开发与质量控制、供应链、注册事务及研发部门紧密合作，确保质量与合规目标的一致性。 Partner with manufacturing,