【Alexion Japan】Manager, Japan Country Quality
About this opportunity
This is what you will do:
【Manager, Japan Country Quality】
製造販売業者の信頼性保証部員として、当該役職者はGlobal AlxionのポリシーおよびSOPに従い、GQP QAグループを管理する。また、QMS管理業務、APJ手順書作成/制定、各品質協定規格締結/遵守、GMPコンプライアンス調査、製造所認定業務などの主要な活動を通じて、適正品質管理（GQP）およびGMDPの準拠を確保することを主たる責務とする。さらにAPJが製造販売業者として顧客クレーム対応も管理する。そのために社内外顧客、即ち、安全性管理部門、サプライチェーン、メディカル、薬事、CMC、営業・マーケティングなどと部門横断的に協働し、所轄当局や共同販売会社と連携・調整を行う。
You will be responsible for:
・開発品から市販後製品としてのGMDP/GQPプロセスのコンプライアンス管理
市販後製品の品質管理システム管理
製造販売業体制管理/主に品責・総責のサポート業務
市販後製品の品質関連業務
You will need to have:
・各種プロジェクト会議を主宰しリードする
QA週例会議において、担当業務におけるトピックを速やかに報告する。
QA月例会議において、品質関連情報のトレンド分析を行い、必要な場合と是正を推進する。
QMS会議/主に変更・逸脱会議/事案に対する対応方針などの検討する
Global組織とのコミュニケーション多数に参加し、APJの情報を報告・協議する。
We would prefer for you to have:
Bachelor’s degree plus more than 5 years-experience in pharma or bio industry
CMC and QA/QC related technical experiences (manufacturing, analytical)
Knowledge of JPAL/ GQP/ GMP requirements
Expert of Quality Management System
Project Management skill (planning, problem solving)
Communication skill
Negotiation skill
Facilitation skill
Problem solving skill
Leadership Capabilities
Date Posted
12-8月-2026
Closing Date
30-8月-2026
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected] . Alexion participates in E-Verify.
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 164 comparable Manager Quality roles across 51 biopharma companies.
Salary context
44 of 164 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 164 comparable roles
+ 19 more countries
Seniority mix
164 of 164 peers have a known seniority level
Therapeutic area mix
0 of 164 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.
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.