スーパーバイザー、コマーシャルクオリティ

Posted Yesterday
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17 Locations
In-Office or Remote
Senior level
eCommerce • Healthtech • Software
The Role
Lead commercial quality assurance for regulated products in Japan (pharmaceuticals, quasi-drugs, cosmetics, medical devices). Maintain QA systems across product lifecycle, lead investigations, deviations, CAPA, change control, and risk assessments. Manage quality at domestic logistics/warehouses, review and approve quality documents, collaborate with Supply Chain and Regulatory Affairs, and drive GMP/GQP training and continuous improvement.
Summary Generated by Built In

Kenvue is currently recruiting for a:

スーパーバイザー、コマーシャルクオリティ

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

コマーシャルクオリティリード

Location:

Asia Pacific, Japan, Tokyo-To, Chiyoda

Work Location:

Hybrid

What you will do

【ポジション概要】

本ポジションは、日本における商用製品の品質保証責任者として、医薬品、医薬部外品、化粧品、医療機器を含む複数の規制カテゴリにわたる製品の品質保証業務を担います。日本の関連法規制および社内品質基準に基づき、製品ライフサイクル全体を通じた品質保証体制の維持・強化をリードし、安定した品質運営を行います。

また、品質課題への対応、逸脱・CAPA管理、文書および変更管理、国内物流拠点・倉庫に対する品質管理を通じて、事業の継続的な成長と信頼性向上に貢献します。関係部門と連携しながら、適切な品質判断と課題解決を推進方が求められます。

【職務内容(役割と責任)】

  • 日本におけるコマーシャルクオリティの品質保証責任者として、適切な品質保証体制の維持・運用を推進する。

  • 製品ライフサイクル全体にわたり、逸脱、品質調査、CAPA、変更管理、品質リスク評価をリードする。

  • 品質およびコンプライアンスに影響する手順書、規格書、品質関連文書、プロセス変更について、レビューおよび承認を行う。

  • 国内の物流拠点・倉庫に対する品質管理および薬事責任者と連携し、必要な確認・評価・改善を推進する。

  • 不適合、逸脱、その他の品質事象に関する調査を主導または調整し、是正・予防措置の実行を推進する。

  • 品質データや逸脱傾向を分析し、継続的改善につなげる。

  • Supply Chain、Regulatory Affairs などの関係部門と連携し、品質リスク評価、課題解決、コンプライアンス維持を推進する。

  • GMP / GQPに関する教育・啓発に貢献し、品質意識の向上を支援する。

【応募資格】

  • 理系学士号または修士号を有する方(薬学、化学、その他関連分野歓迎)。

  • 薬剤師資格を有する方歓迎。

  • 規制対象業界において、品質保証、製造品質、または規制コンプライアンスに関する実務経験を5年以上有する方。

  • 医薬品、医薬部外品、化粧品、医療機器など、複数の規制カテゴリに関する理解または実務経験をお持ちの方。

  • 日本の関連法規、GMP、GQPに関する知識を有する方。

  • 逸脱、不適合、品質調査、CAPA、変更管理、リスク評価に関する実務経験を有する方。

  • 論理的思考力、判断力、関係者を巻き込みながら業務を推進する力を有する方。

  • 日本語で円滑にコミュニケーションできる方。

  • ビジネスレベル以上の英語スキル(読み書き)

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Skills Required

  • Bachelor's or Master's degree in a science field (pharmacy, chemistry, related)
  • Pharmacist license
  • 5+ years' practical experience in quality assurance, manufacturing quality, or regulatory compliance in regulated industries
  • Understanding or practical experience across multiple regulated categories (pharmaceuticals, quasi-drugs, cosmetics, medical devices)
  • Knowledge of Japanese laws/regulations and GMP and GQP standards
  • Practical experience with deviations, nonconformances, quality investigations, CAPA, change control, and risk assessment
  • Ability to analyze quality data and drive continuous improvement
  • Strong logical thinking, judgment, and ability to lead stakeholders to resolution
  • Fluent Japanese communication skills
  • Business-level English reading and writing

Kenvue Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Kenvue and has not been reviewed or approved by Kenvue.

  • Fair & Transparent Compensation Pay is considered decent and competitive for the work performed. Base compensation combined with a solid benefits package supports a generally fair total rewards perception.
  • Healthcare Strength Comprehensive healthcare, life insurance, and disability plans are emphasized. Access to mental health resources and assistance programs further strengthens perceived health protection.
  • Parental & Family Support A global parental leave policy and support for adoption, fertility, and surrogacy are highlighted. These offerings contribute to a family‑friendly and supportive package for diverse families.

Kenvue Insights

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The Company
HQ: Summit, New Jersey
17,919 Employees
Year Founded: 2023

What We Do

Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage and propelled forward by science, our iconic brands — including Aveeno®, BAND-AID® Brand Adhesive Bandages, Johnson’s®, Listerine®, Neutrogena®, Tylenol® and Zyrtec® — are recommended by health care professionals and can be trusted by consumers who use our products to improve their daily lives. Our team members share a digital-first mindset, with an approach to innovation grounded in deep human insights and work every day to earn a place for our products in consumers’ hearts and homes. At Kenvue, we believe everyday care can not only make people well; it can make them whole. Beware of recruitment scams: https://www.kenvue.com/media/recruitment-scams-alert

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