QA Associate Director

BioNTech · Zhuhai

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横琴，中国   |   全职   |   Job ID: 11644 

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, analytical development and quality control, supply chain, regulatory affairs, and R&D to ensure alignment on quality and compliance objectives.
• 作为 GMP 质量保证（QA）代表，参与监管检查、合作伙伴审计及尽职调查活动。
  Represent GMP QA in regulatory inspections, partner audits, and due diligence activities.
• 识别、评估并降低横琴产品在整个供应链（端到端）中的 GMP 相关风险。
  Participate in identification, assessment, and mitigation of GMP-related risks across the supply chain (end to end) for Hengqin products.
• 确保 CDMO 遵守合同义务、质量协议及监管法规要求。
  Ensure CDMOs’ compliance with contractual obligations, quality agreements and regulatory requirements
• 在团队内部和跨职能团队以及与CMDO之间，培育注重质量、担当与协作的文化。
  Foster a culture of quality, accountability, and collaboration within the team and across the organization and with CMDOs.
• 上级领导安排的其他工作。
  Other tasks assigned by senior management.

A good match:

• 应具备本科及以上学历，药学、生物、化学、质量管理或相关专业；硕士及以上学历优先。
  Candidates must hold a bachelor’s degree or higher in pharmacy, biology, chemistry, quality management or a related discipline； Master or higher is preferred.
• 具备生物制品或药品生产质量保证15年及以上相关经验。
  At least fifteen years’ relevant experience in quality assurance for the manufacture of biological products or medicine
• 在全球性组织中领导GMP质量保证（QA）职能方面拥有经证实的成功履历及相关行业经验；能够适应快节奏、充满活力且工作重点不断变化的环境。
  Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.
• 深刻理解全球GMP法规、ICH指导原则及单克隆抗体生产工艺。
  Strong knowledge of global GMP regulations, ICH guidelines, and monoclonal antibody manufacturing processes.
• 具备卓越的领导力以及出色的分析、解决问题和决策能力。
  Exceptional leadership skills, strong analytical, problem-solving, and decision-making abilities.
• 具备任务统筹、人员指导、跨部门沟通、冲突协调和风险升级能力，原则性强并能保持QA独立判断。
  Possess the ability to coordinate tasks, supervise staff, liaise across departments, resolve conflicts and escalate risks; demonstrate a strong sense of principle and maintain independent judgement in QA matters.
• 具备优秀的沟通与人际交往能力，能够影响各级利益相关者。
  Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• 具备出色的英语口语及书面沟通能力。
  Excellent English language for verbal and written communications
• 具备战略思维，注重持续改进与创新。
  Strategic thinker with a focus on continuous improvement and innovation.
• 该职位可能需要出差（最高达30%），以进行审计、PIP相关工作及各类会议。
  This role may require travel (up to 30%) for audits, PIPs, and meetings.

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