Mgr, Supplier Quality

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

APAC全体の品質組織の ECM およびサプライヤー品質部門の技術専門家として勤務します。品質と規制および Vantive 品質ポリシーへの準拠に関する結果に責任を負います。

Serves as the technical expert within ECM & Supplier Quality department(s) in the Quality organization. Is responsible for results in terms of quality and conformance to regulations and Vantive quality policies.

【仕事内容】

- サプライヤーに対する品質システム要件の設定と管理

- 医療機器や医薬品のサプライヤーの資格認定と監督

- サプライヤーの品質監査の実施と結果の解決

- サプライヤーの品質データの収集と分析、報告

- サプライヤーの品質システムの改善と開発

- 購買管理プロセスの開発と改善

- 外部機関の検査や内部監査の準備と対応

- 購買管理の是正措置活動（CAPA）の管理

- 内部チームやサプライヤーへのトレーニング実施

- 施設の取得や売却に関する調整と確認

- 海外出張を含む（月1回程度）

【必要な資格・経験】

- 医薬品および医療機器の規制に関する知識（ISO 13485、FDA cGMPなど）

- 米国および国際的なcGMP（APIおよび賦形剤）の実務知識

- 製品/プロセス開発およびサプライヤー品質改善の経験

- 製造/品質開発および管理方法に関する良好な知識（CtQ定義、DfSS、SPC、APQP、FMEA、コントロールプランなど）

- 監査スキル（SQリード監査人認定トレーニングを含む）

- ビジネス判断力、優れたコミュニケーションおよびチームワークスキル

- プロジェクト管理スキル

- サプライヤー品質開発のサポート能力

- マルチタスクスキルと優れた時間管理能力

- 細部への注意と品質への情熱

- 英語での優れた書面および口頭のコミュニケーションスキル

【教育および経験】

- 科学分野の学士号（7年以上の経験）または修士号（5年以上の経験）

- 品質、製造、エンジニアリングまたは関連分野で5年以上の経験

- 製薬製造の経験が望ましい

- 実験室方法の実行経験

- 薬品製造施設の監査経験

- 根本原因分析、是正および予防措置の経験

- データ分析と報告の経験（Excel、Minitab、Visio、PowerPointなど）

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【Job Description】

Manage supplier quality assurance activities within the quality organization. Specific tasks include:

- Setting and managing quality system requirements for suppliers

- Qualifying and overseeing suppliers for medical devices and pharmaceuticals

- Conducting supplier audits and resolving audit findings

- Collecting, analyzing, and reporting supplier quality data

- Improving and developing supplier quality systems

- Developing and improving purchasing management processes

- Preparing for and responding to external and internal audits

- Managing corrective actions (CAPA) for purchasing controls

- Providing training to internal teams and suppliers

- Coordinating and confirming facility acquisitions and divestitures

- Willingness to travel (up to 30%)

【Qualifications】

- Knowledge of pharmaceutical and/or medical device regulations (e.g., ISO 13485, FDA cGMP)

- Working knowledge of US and international cGMP for API and excipients

- Experience in product/process development and supplier quality improvement

- Good knowledge of production/quality development and control methods (e.g., CtQ definition, DfSS, SPC, APQP, FMEA, control plans)

- Auditing skills, including certified SQ lead auditor training

- Business acumen, excellent communication, and teamwork skills

- Project management skills

- Ability to support supplier quality development

- Multi-tasking skills and superior time-management skills

- Attention to detail and passion for quality

- Superior written and oral communication skills (in both Japanese and English)

【Education and Experience】

- Bachelor's degree in a scientific discipline (7+ years of experience) or Master's degree (5+ years of experience)

- 5+ years of experience in quality, manufacturing, engineering, or a related field

- Preferred experience in pharmaceutical manufacturing

- Experience performing laboratory methods

- Experience auditing drug manufacturing facilities

- Experience in root cause analysis and corrective/preventive actions

- Experience with data analysis and reporting (Excel, Minitab, Visio, PowerPoint)

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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