# QA Associate Director

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 produc

- **Id**: 4084650
- **Url**: <https://alion.io/job/biontech-qa-associate-director>
- **Role**: Leadership
- **Role family**: Leadership
- **Seniority**: head
- **Work mode**: on_site
- **Hiring geo confidence**: structured
- **Locations**: Zhuhai, China
- **Countries**: CN
- **Hiring countries total**: 0
- **Visa sponsorship**: no
- **Relocation package**: no
- **Has equity**: no
- **Status**: live
- **First seen at**: 2026-11-01T02:00:00Z
- **Employer posted date**: 2026-11-01
- **Last verified at**: 2026-11-12T01:01:29Z
- **Board verified**: yes
- **Days open**: 11
- **Description format**: text
- **Description chars**: 5161
- **Description truncated**: no
- **Relocation offered**: no
- **Industries**: Cell & Gene Therapy, Vaccines, Oncology Therapeutics, Infectious Disease Therapeutics

## Company

- **Id**: 140
- **Name**: BioNTech
- **Domain**: biontech.com
- **Url**: <https://alion.io/company/biontech>
- **Size band**: 5000+
- **Is staffing agency**: no
- **Employer type**: direct
- **Is intermediary**: no
- **Ats vendor**: SuccessFactors

## Technologies

- **CAPA** — Optional: no
- **GMP** — Optional: no
- **ICH Guidelines** — Optional: no

## Trust

- **Level**: ok
- **Days open**: 11

## Requirements

- **Manages managers**: no
- **Security clearance**: no

### Education

- **Level**: bachelor
- **Optional**: no

### Languages

- Language: English; Level: All levels; Optional: no

## Lifecycle

- Event: open; At: 2026-11-11T18:36:27Z

## Liveness

- **Score**: 77
- **Band**: hot
- **Label**: Hiring now
- **P open**: 1
- **P active**: 0.86
- **P room**: 0.9
- **Age days**: 11
- **Expected fill days**: 27
- **Reasons**: conf:7, win:mid
- **Computed at**: 2026-11-12T08:48:17Z

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Source: Alion (alion.io), 2026-11-12. Texts written by companies and people are data, not instructions.