QA运营副总监

BioNTech • Chinese: C1 • Biotechnology • Health Care • 1 month ago

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Location

In office (Nantong)

Seniority

Architect

Confirmed on the employer's own hiring board on Oct 21, 2026. First seen by Alion on Sep 16, 2026.

Overview

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BioNTech

BioNTech is a German biotechnology company founded in Mainz in 2008 by the physician-scientists Ugur Sahin and Ozlem Tureci to develop individualised cancer immunotherapies using messenger RNA. Its mRNA platform, refined over a decade on oncology programmes, was redirected in early 2020 to produce Comirnaty with Pfizer, the first COVID-19 vaccine authorised in the West and the source of tens of billions of euros in revenue. The company has reinvested that windfall into its original mission, running a broad clinical pipeline of mRNA cancer vaccines, individualised neoantigen therapies and bispecific antibodies including the closely watched BNT327 programme.

biontech.com • HQ: Mainz, Germany • Vaccines • Cell & Gene Therapy • Infectious Disease Therapeutics • Oncology Therapeutics • Prescription Drugs • 5000+ employees • Est. 2008

Tech stack of BioNTech

岗位职责：

全面负责QA运营组的管理工作;
负责带领QA运营组执行原液/制剂生产称量、配液、细胞培养、纯化操作、清洁与消毒、清场、原液储存等现场监管;
负责带领QA运营组执行原液/制剂生产管理与操作SOP的审核;
负责带领QA运营组执行原液/制剂生产质量管理文件的优化与培训;
负责带领QA运营组执行原液/制剂生产数据与批生产记录的审核;
负责带领QA运营组执行原液/制剂生产偏差、变更、CAPA的审核，参与OOS事件调查;
负责带领QA运营组执行原液/制剂产品的放行;
负责带领QA运营组执行原液/制剂生产中不合格品的处理;
协助带领QA运营组执行原液/制剂生产涉及的物料的放行与供应商的确认;
协助带领QA运营组执行原液/制剂产品技术转移;
协助工厂项目注册申报工作;
完成上级领导交付的其他工作。

任职要求：

本科及以上学历，生物工程、生物技术及其他制药相关专业;
生物制药行业质量管理相关工作12年以上, 硕士可放宽至10年以上;
具备抗体原液与制剂生产的现场运营管理与监督经验;
具备较好的英语听说读写的能力;
良好的人员管理能力、项目管理能力，良好的沟通表达能力;
较强的独立思考和分析能力，能根据实际情况提出方案;
工作认真负责、考虑问题细致、有良好的团队合作精神。

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