Senior Director External Manufacturing QA (Shanghai, SH, CN, 200050)
About this opportunity
中国，上海 | 全职 | Job ID: 11608
Position Summary:
BioNTech pursues an increasing external manufacturing strategy with a focus on China. CDMOs do not ultimately carry pharmaceutical responsibility and demand continuous oversight to ensure GMP compliance following basic GMP principles e.g. (GMP for MAH) as well as quality performance to BNTs expectations ultimately ensuring good batches coming from these CDMOs.
This role will ensure BNTs pipeline manufacturing and supply with a focus onto Asia / China and oversee execution of pharmaceutical quality and compliance performance considering international GMP expectations as well as BNTs Quality Agreements and expectations.
Your main responsibilities are:
Actively oversee all relevant CDMOs in Asia with regard to manufacturing, GMP authority interactions, inspections to ensure overall understanding and mitigation of risk in regard to BNTs products
Execute on-site visit to reactively review issues and/or pro-actively mitigate potential risk
Support and oversee all relevant audits as well as inspection at CDMOs with regard to BNTs products
Define, initiate, guide and close out BNTs Person-in-Plants presence at respective CDMOs
Ensure execution of pharmaceutical activities based on the closed contracts with special focus on the Quality Assurance Agreements in place
Build sustainable and trustful business relationships with key leaders – especially – quality leaders from our partners in the manufacturing network
What you have to offer:
At least several years of experience in the pharmaceutical industry and should have had at least one key role leading a team; ideally site quality head
Managed successfully inspections and audits for a manufacturing site
Been exposed to different Asian regions, best would be China and Singapore as well as European and US
Fluently talk in mandarin/Chinese and English
Has been exposed to the CDMO business
Has in-depth knowledge and experience for GMP
BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。
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提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。
我们诚挚期待您的加入。
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 61 comparable Senior Director Quality roles across 27 biopharma companies.
Salary context
32 of 61 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 61 comparable roles
+ 10 more countries
Seniority mix
61 of 61 peers have a known seniority level
Therapeutic area mix
0 of 61 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
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How we calculate "similar"
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Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.