Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Radiometer, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here, you'll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
Learn about the Danaher Business System which makes everything possible
The Principal Specialist, Commercial RAQA is responsible for serve as General Marketing Supervisor (Soseki/MAH) under the PMD Act, ensuring compliance with all applicable QMS and GVP requirements and more.
This position reports to DHR Dx Commercial QARA manager and Radiometer Japan General Manager and is part of the QARA team located in Tokyo and will be onsite.
職務概要
Danaher グループの事業会社の日本法人を横断的に統括する QRA チーム(Center Of Excellence; COE)に所属し、Danaher グループの事業会社における品質保証関連業務、薬事申請業務及び薬事関連規制の遵守管理に係る実務を担当します。
また、本ポジションは、グローバルのR&Dおよび製造拠点と連携し、品質モニタリングおよび改善活動を通じて、製品およびプロセスの継続的な向上を推進します。
<ラジオメーター社員としての職務>
総括責任者として、日本における品質・薬事機能を統括し、市販されている体外診断用医薬品および医療機器製品が、日本の関連法規、ISO 13485およびグローバル品質基準に確実に適合していることを保証します。
本ポジションは薬機法に基づく総括製造販売責任者(Soseki/MAH)として、品質保証責任者(Hinseki)および安全管理責任者(Anseki)と協働し、製品の品質・有効性・安全性を製品ライフサイクル全体で担保します。
主な職務内容
- 総括製造販売責任者(Soseki/MAH)として薬機法に基づくQMS・GVP関連要件を遵守し、製造販売業者としての責任を果たす。
- 品質保証責任者(Hinseki)および安全管理責任者(Anseki)と協働し、市販後製品の品質および安全性を確保する。
- PMDAや東京都など当局の査察・監査への対応をリードし、是正措置(CAPA)を適切に完了させる。
- 日本の品質マネジメントシステム(QMS)をISO 13485、QMS省令および社内品質方針に沿って維持・改善する。
- 苦情処理、回収、安全管理(Vigilance)、出荷判定業務を統括する。
- 製品品質のパフォーマンスおよび市場からのフィードバックをモニタリングし、不具合傾向を分析してグローバル関係者へ報告する。
- グローバルR&Dおよび製造拠点と連携し、根本原因の特定および設計・工程改善を推進する。
- 公正取引、表示・広告審査、販促資材レビューを含む法令遵守を推進する。
- リスクベースの意思決定と継続的改善を推進し、コンプライアンス文化を醸成する。
- 部下の能力開発と評価を実施し、後継者育成および組織の持続的成長を確保する。
応募要件
- 薬学、化学、または関連理系分野の学士または修士号。
- 薬剤師免許(必須)。
- 医療機器または体外診断用医薬品業界における品質保証または薬事関連業務経験10年以上。
- 総括、品質保証責任者、安全管理責任者のいずれかの実務経験を有することが望ましい。
- チームマネジメントおよび人材育成の実績。
- 薬機法、ISO 13485、QMS省令、GVPに関する深い理解。
- 日本語での高いコミュニケーション能力およびビジネスレベルの英語力。
- グローバルマトリクス型組織での協働経験を有する方。
求める人物像
- 高い倫理観と責任感を持ち、適切な判断に基づく意思決定ができる方。
- コンプライアンスと事業の両立を意識した戦略的思考とアジリティを持つ方。
- 部門横断的なチームを牽引し、メンバーの意欲を高めるリーダーシップを発揮できる方。
- 国内外の関係者と明確かつ効果的にコミュニケーションが取れる方。
- 継続的改善の意識を持ち、率先して品質文化と信頼を醸成できる方。
- 高いストレス耐性を持ち、査察や組織変化といったプレッシャー下でも冷静に対応できる方。
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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