苏州招聘

Title:Director of Quality Assurance
Reports to:Corporate Legal Representative (as specified by law in China)
Education Level:BA or BS plus a minimum of 5 years experience in Quality Assurance in the biopharmaceutical industry
Salary Range
Benefit Package:As defined by company policy
Direct Reports:Manager of Documentation


Responsibility: Oversee Quality Assurance functions.
The Director or Manager of Quality Assurance is responsible for the Quality Assurance program at Innovent. According to Chinese law this individual reports to the company Legal Representative. The primary responsibility of the Director or Manager of Quality Assurance is the release of drug substance and drug product. The Director or Manager is also responsible for the controlled document system and the documents within the system.

The director or manager is responsible for interpreting the company goals into an action plan and carrying out this plan to ensure company goals are achieved. The director is also responsible for transfer of cell culture processes from development into manufacturing.

The director or manager is also responsible for cGMP training, compliance and facility validation， review and approve URS, SAT, FAT, assay qualification, validation documents

The director or manager is responsible for the growth and development of staff within the Quality Assurance area. This includes compliance with company policies and diligence in ensuring a safe and professional work environment. The director or manager is responsible for the training of development personnel in job skills, safe work practice and cGMP.

Qualifications: Extensive experience in Quality Assurance for monoclonal antibodies and other recombinant proteins.

The director or manager is expected to be a technical expert in the area of Quality Assurance and cGMP compliance. This includes familiarity and experience with the technical issues related in the manufacture, testing and characterization of recombinant proteins. The head of Quality Assurance is expected to have sufficient technical background to evaluate issues based on the science and not rely solely on historical precedent.

The director or manager should have experience in the development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions.

The director should have a college degree in an applicable scientific discipline and a minimum of 5 years experience in biopharmaceuticals. Chinese language skill is a plus.

职位名称： 质量保证部总监

学历： 学士以上，5年以上生物制药产业品质管理工作经验

汇报对象： 公司法人代表

下属： 文档经理

职责：
根据中国法律要求此岗位直接向公司法人代表汇报，全面统筹管理整个公司的质量管理工作，负责部门员工的招聘，培训，工作安排，绩效考核等，具体还包括：
1. 负责公司原料药投入和成品药产出的品质控制；
2. 公司的产品及生产设施质量是否符合国家规章制度验证，以及厂房，工艺质量验证；
3. 负责质量保证文件系统及系统内文件管理；
4. 负责质量保证部们人员专业技能，工作安全，cGMP培训 。

要求：
1. 具有单克隆抗体和重组蛋白质品质管理方面的丰富工作经验
2. 精通重组蛋白质的检测，认证，生产
3. 具备独立科学地评估处理品质问题的专业能力
4. 具有在美国和欧洲注册的生物制药产品的开发经验，包括相关注册文件准备的经验
5. 具有相关科学专业的大学学士以上学位
6. 至少五年生物制药公司质量保证工作经验
7. 会中文者优先

信达生物成立于2011年，致力于开发、生产和销售用于治疗肿瘤等重大疾病的创新药物。2018年10月31日，信达生物制药在香港联交所主板挂牌上市，股票代码：01801。

自成立以来，公司凭借创新成果和国际化的运营模式在众多生物制药公司中脱颖而出。建立起了一条包括32个新药品种的产品链，覆盖肿瘤、代谢疾病、自身免疫等多个疾病领域，7个产品（信迪利单抗注射液，商品名：达伯舒，英文商标：TYVYT；贝伐珠单抗生物类似药，商品名：达攸同，英文商标：BYVASDA；阿达木单抗生物类似药，商品名：苏立信，英文商标：SULINNO；利妥昔单抗生物类似药，商品名：达伯华，英文商标：HALPRYZA；pemigatinib口服抑制剂，商品名：達伯坦，英文商标：PEMAZYRE；奥雷巴替尼片，商品名：耐立克；雷莫西尤单抗，商品名：希冉择，英文商标：CYRAMZA）获得批准上市， 1个品种在NMPA审评中，另外还有19个产品已进入临床研究。

信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队，包括众多海归专家，并与美国礼来制药、Adimab、Incyte、MD Anderson 癌症中心和韩国Hanmi等国际合作方达成战略合作。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。

“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的理想和目标。