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Johnson & Johnson キャリア

【Janssen】※緊急※ (Fuji) Quality Compliance Manager

富士市, 日本
Quality (Generalist)


Requisition ID: 1805705611W

Quality Compliance manager is a key position in the Janssen Fuji site, as he/she is ultimately responsible for ensuring the overall compliance status for all the activities performed at JPKK-Fuji. The position is also a key link between the regulatory authorities, internal and external partners leading audits and inspections. 

品質コンプライアンスGマネージャーは、ヤンセンファーマ株式会社富士工場で実施される全てのアクティビティの総合的なコンプライアンスステータスを最終的に保証する責任があるため、ヤンセンファーマ株式会社富士工場の重要なポジションとなります。 このポジションは、規制当局、内部および外部のパートナーによる監査および査察間との重要な繋がりとなります。

Key responsibilities of Quality Compliance Manager are品質コンプライアンスG マネージャーの主な責務:
  • Leading the Quality Compliance team and having an oversight on all the Quality Compliance processes followed at the site.
  • Providing leadership, where required, on troubleshooting/issue resolution, etc.
  • Ensuring that all the expected Japanese regulations are complied at Fuji site.
  • Providing people leadership either directly through line leadership (his/her team) or indirectly (projects/matrix organization)
  • Good Manufacturing Practices (GMP) – Adhere cGMP as per Japan authorities and as per Global J&J/JANSSEN Policies.
GMP(Good Manufacturing Practices) - 日本の当局およびグローバルJ&J / JANSSEN Policyに従ってcGMPを遵守する
  • EHS – Adhere to Janssen global standard related EH&S.
EHS - Janssenの世界標準規格に関連するEH&Sに準拠する
  • Narcotics and Psychotropic Control Law – Adhere to narcotics and psychotropic Control Law.
麻薬および向精神薬の規制法 - 麻薬および向精神薬の規制法を遵守する
  • The Pharmaceutical Affairs Law – Adhere to the Japanese pharmaceutical affairs law
薬事法 - 日本の薬事法を遵守する
<Role and Responsibilities 役割と責務>
  • Leading the Quality Compliance team and have an oversight on the day to day activities done by the Quality Compliance team at Fuji site.
  • 品質コンプライアンスチームを率い、富士サイトの品質コンプライアンスチームの日々の活動をリードする
  • Allocate the work to the team and ensure appropriate distribution of work throughout the team.
  • 業務をチームに割り当て、チーム全体で業務を適切に分担する
  • Have an oversight of all the activities owned by Quality Compliance group. As an example – Change Control, Training, Document Control, Internal Audits etc.
    品質コンプライアンスグループが有する全てのアクティビティを監督する (例: 変更管理、トレーニング、文書管理、内部監査など)
  • Perform continuous improvement of the Quality Compliance processes to make it more smart and efficient, keeping the compliance part intact.
  • 品質コンプライアンスプロセスをコンプライアンス/法令遵守を損なわずに継続的に改善し、よりスマートで効率的なものにする
  • Ensure that the Quality group and eventually the entire site follows the regulatory requirement as per the Japan requirement.
  • Lead the people training and development plans for the Quality Compliance team and ensure appropriate resources are available to manage all the activities of Quality Compliance.
  • Maintain the budget for the Quality Compliance group and ensure that the budget is maintained within the allocated finances.
  • Perform document review and approvals for all the applicable documents required at the site.
  • Perform QA approval of all the validation related documents.
  • Have close contact and communication with the other sites as well as external personnel to ensure best practices are shared and implemented.
  • 他のサイトや外部担当者と密接に連絡を取り合い、ベストプラクティスが共有され、実施されていることを保証する
  • Provide guidance for compliance related activities as well as lead investigation and trouble-shooting along with initiation of appropriate CAPA to prevent the recurrences.
  • 再発防止のための適切なCAPAを実施すると共に、コンプライアンス関連のアクティビティについての指導、主導的な調査およびトラブルシューティングを行う
  • Perform risk assessment for any change items and decide all actions related to validation and qualification.
  • Provide compliance as well as regulation related training and consultation to relevant department.
  • Have a responsibility to lead and actively participate in GMP audit by Regulatory Authorities. Prepare and participate in the Internal and Janssen Global audits. 
    規制当局によるGMP監査を主導し積極的に参加する責任を負う。 内部監査およびJanssen Global監査を準備し、それらに参加する。
  • Connect and collaborate with Business Quality on a routine basis for exchange of information. Ensure the regulatory notifications are handled as per the procedure in the Fuji site.
  • Business Qualityと常に協力し情報交換を行う。 当局への届け出が富士のサイトの手順に従って処理される事を保証する
  • Perform global projects as required by the business and needs.
  • Build strong relationships with global, regional and local organizations that are relevant to Quality Assurance and Compliance.
  • Be qualified as security pharmacist as per the requirements of Janssen Japan.
    Janssen Japanの要件に従って医薬品製造管理者として任命を受ける
  • Support in handling of controlled substances as required.


  • EDUCATION/EXPERIENCE: (Essential)学歴/職務経験(必須)

  • This position requires the candidate to be a pharmacist or at the minimum Master or Bachelor’s in science (minimum)
  • 薬剤師、または最低でも理学系の修士号または学士号の取得者
  • 3 to 5 years of Quality Assurance / Quality Control / Production experience in the industry.
  • 3〜5年の品質保証、品質管理、または製造での職務経験
  • Should have experience of leading a team of minimum 5 people
  • 最低でも5人のチームをリードした経験
  • Should be well versed in English communication, besides being able to converse in Japanese.
  • 日本語堪能、英語でのコミュニケーションに精通している事
  • Should have experience of being a team player and maintain an excellent relationship between the cross functional teams within the site, wider organization as well as with the external partners
  • チームプレーヤーとして工場内の他部門やより幅広い組織、および外部パートナーとの間で優れた関係を維持した経験がある
  • EDUCATION/EXPERIENCE: (Desirable)学歴/職務経験(優遇)
  • At least 5 years of experience in a manufacturing facility function, with at least 3 years in Quality Assurance function
  • 製造部門で5年以上、品質保証部門で3年以上の経験
  • Working with diverse culture is desirable
  • 多様な文化での職務経験が望ましい

Janssen Pharmaceutical K.K. (7195)
Quality (Generalist)
Requisition ID