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岗位职责：
- 负责MAH质量体系建设中运营板块的建立与维护；
- 负责MAH委托生产质量监督管理的建设与执行；
- 负责MAH委托生产中的偏差、变更与CAPA的管理和审核；
- 负责MAH委托生产批记录和检验记录的审核；
- 负责MAH委托生产日常业务的沟通和跟进；
- 参与第三方或药政审计接待与准备工作，及后续的回复；
- 负责收集委托生产中产生的数据并进行趋势分析及持续改进；
- 负责与受托生产工厂配合持续提升委托生产的质量管理水平
- 负责产品上市放行前的审核工作
- 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；
- 制药行业质量运营管理相关工作6年以上，其中生物药质量体系2年以上；
- 良好的英文读写能力；
- 英文CET-4以上。
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About BioNTech
BioNTech
PublicBioNTech SE is a German multinational biotechnology company headquartered in Mainz that develops immunotherapies and vaccines, particularly for cancer and infectious diseases.
1,001-5,000
Employees
Mainz that develops immunotherapies
Headquarters
$21.7B
Valuation
Reviews
4.0
10 reviews
Work-life balance
2.5
Compensation
3.8
Culture
4.2
Career
3.5
Management
3.2
75%
Recommend to a friend
Pros
Innovative and cutting-edge projects
Great team and collaborative environment
Excellent benefits and flexible schedule
Cons
Long working hours and high workload
Fast-paced and high-pressure environment
Management and communication issues
Salary Ranges
70 data points
Mid/L4
Mid/L4 · Project Manager
3 reports
$122,537
total per year
Base
$106,811
Stock
$9,411
Bonus
$6,316
$88,589
$172,342
Interview experience
1 interviews
Difficulty
3.0
/ 5
Duration
14-28 weeks
Interview process
1
Application Review
2
HR Screen
3
Hiring Manager Interview
4
Panel Interview
5
Final Interview
6
Offer
Common questions
Behavioral/STAR
Technical Knowledge
Past Experience
Culture Fit
Problem Solving
News & Buzz
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simplywall.st
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4d ago
Biontech prepares FDA application after strong phase II results in endometrial cancer - medwatch.com
medwatch.com
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1w ago
BioNTech and DualityBio report positive data for trastuzumab pamirtecan - Clinical Trials Arena
Clinical Trials Arena
News
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1w ago