About this opportunity
岗位职责:
负责工厂体系文件的维护与更新,确保体系的正常运行;
负责偏差、变更、CAPA和质量风险管理等合规审核;
负责协助外部客户与药监机构的检查工作,及回复和整改;
负责组织偏差审核会议、变更审核会议,并反馈审核结果;
负责支持定期质量管理评审,分析质量体系数据;
负责支持质量电子系统的上线,以及相关的质量项目的完成;
负责根据新颁布法律法规的差异分析结果进行体系优化;
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5年以上;
英文CET-4以上,具备良好听说读写能力。
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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 195 comparable Senior Quality roles across 49 biopharma companies.
Salary context
59 of 195 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 195 comparable roles
+ 21 more countries
Seniority mix
195 of 195 peers have a known seniority level
Therapeutic area mix
0 of 195 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
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.