(Associate) QA Director

南通，中国; 珠海，中国 | 全职 | Job ID: 11669

About the role:

百欧恩泰（珠海） MAH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，该负责人将建立和提升百欧恩泰（珠海） MAH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。该岗位负责产品放行给临床试验和商业化市场 ​The QA Head for BioNTech-Zhuhai MAH is a leadership role responsible for the quality assurance of the drug products manufactured by BioNTech subsidiaries or CDMOs. The incumbent will ensure quality compliance with China regulatory requirements, industry standards, and BioNTech internal policies, standards, and SOPs for the manufacturing, testing, release and distribution of biological products (clinical and commercial). The incumbent will establish and improve the BioNTech MAH QMS for the assurance of drug products and oversight of the CDMO activities and drive continuous improvement initiatives, work with cross-functional teams, and ensure the highest standards of product quality and patient safety. The incumbent will be responsible for drug product release for both clinical trials and commercial markets.​

Your contribution:

• 负责MAH质量体系的建立和完善，确保其有效运作，制定质量战略目标及年度工作重点，管理百欧恩泰珠海（MAH）公司质量运营工作

Set up effective MAH quality systems and continuously improve them; develop annual strategic quality goals; and lead quality operations of BioNTech (Zhuhai)

• 负责国内药监机构GMP检查工作; 协助检查组开展现场检查，负责检查发现项回复, 整改工作进行，确保各项发现项的整改工作按时完成

Oversee all GMP inspections by Chinese regulatory agencies and assist inspectors to perform effective inspections, lead inspection response to the inspection findings/observations if any, development of CAPA for the inspection findings, and ensure the timely completion of the CAPAs related regulatory inspection findings/observations

• 审核偏差和检验结果超标的处理报告，跟踪产品质量问题，分析质量偏差的根本原因，并提出方案确保偏差等问题得到及时处理

Review and approve the deviations, OOS, complaints and change controls; follow up critical product quality related issues; review root cause analysis trends for quality deviations and the effectiveness of implemented CAPAs, other key quality performance metrics

• 审核产品的工艺规程、质量标准、取样方法、检测方法和其他质量管理的操作规程、以及与质量有关的所有的变更

Review manufacturing process procedures, specifications, sampling methods, testing methods and other quality management SOPs, as well as all quality-related changes

• 审核工艺验证方案和报告，确保各项必要的验证工作得到及时完成

Review process validation protocols and reports, ensure all the necessary verifications and validation are completed in time

• 承担产品放行的职责，确保每批产品放行前，完成所有必要的检验和对批记录的审，放行产品的生产、检验均符合相关法规、药品注册要求和质量标准

Be responsible for product release. Ensure that all tests have been completed and the batch records have been reviewed before release of a product to ensure that the production and testing of each batch of released products are in accordance with the relevant regulations, the registration requirements and specifications

• 主导不良反应和产品召回的及时有效处理

Lead the adverse drug reaction and product recalls are timely and effectively handled

• 监管委托生产商，委托实验室及其他服务商符合法规要求和百欧恩泰珠海（MAH）的标准

Oversee contract manufacturers, contract laboratories, and other service providers, and ensure they meet the relative regulatory requirements and BioNTech’ standards

• 确保公司培训管理包括员工入职培训与持续培训，并培训有效并应符合每个的实际需要

Ensure that the training program including new employee training and continuing training of the personnel is effective and meets the requirements for each employee to do his or her job

• 批准和监管物料供应商,并与主要和关键物料供应商签订质量协议

Approve and monitor material suppliers and contract service providers and sign quality agreements with major and critical suppliers

• 参与工艺性能、产品质量与质量管理体系的管理评审并提倡持续改进

Participate in management reviews of process performance, product quality standards, and the quality management system, and advocate continual improvement

• 确保有及时有效的沟通机制和逐级汇报程序，将质量问题汇报到适当的管理层

Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate management levels

• 负责新产品质量文件和技术从研发到生产的转移,到商业化生产

Take charge of transferring quality documents and technologies of new products from R&D to manufacturing transfer, to commercial manufacturing

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, 其中担任质量负责人/质量受权人级职位5年及以上​

At least fifteen years’ relevant experience in quality assurance for the manufacture of biological products or medicines, including at least five years in a position at the level of Quality Head or Qualified Person.

• ​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;主导和参与过国内外现场核查等，有新产品、新工艺等技术转移项目经验

​Proven track record and relevant industry experience in leading GMP QA functions within a global organization, with experience in leading or participating in domestic and international regulatory on-site inspections; experience with technology transfer projects of new products or processes.

• ​有强烈的敬业精神和基本职业道德，有事业抱负，进取心强; 能够适应快节奏、充满活力且工作重点不断变化的环境

​Strong dedication and professional ethics; ambitious and highly motivated; 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.

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