エージェント取り扱い求人

Learning Lead, Narita Site/ 成田工場 ビジネスエクセレンス室 ラーニングリード(主席部員)

募集中
  • 勤務地
    千葉県
  • 職種
    その他製剤化/製造・生産関連職
  • 業種
    医薬品メーカー(先発医薬品)

募集要項

業務内容 職務内容

このポジションの主な目的は、サイト品質システム&コンプライアンスリードと協力して、パフォーマンス能力を構築し、強化し、GMSGQ内のトレーニングに関するグローバル基準へのコンプライアンスを確保するために、サイトのGxP学習システムを開発し、維持することです。

サイトのラーニングリードは、頑健なトレーニングニーズ分析に基づいてサイトのGxP学習計画を確立し、複数の部門にわたるGXP規制対象の製造環境に関する業務上のコンピテンシー要件を提供し、サイトのニーズと事業目的に基づいてGMS学習戦略を実施する責任を負います。

GMPトレーニングの監督に責任を負う品質システムの社員と協力して、サイトのニーズを満たすために効率的、効果的、適合性のある学習システムが整備されていることを保証するために、グローバルトレーニング方針及びGOP(グローバル作業手順書)の実施を監督します。関連するアプリケーション管理と展開を含む、LMS(Learning Management System)プラットフォームの継続的な展開及び使用を管理する責任を負います。

また、任命されたグローバルラーニングチームのビジネスパートナーと協力して、頑健な学習システム要素が整っていること、及びサイトが使用するための適切な技術的学習ソリューションが提供されていることを確認します。サイトの標準構造に従い、トレーニングはサイトレベルでビジネスエクセレンスに報告し、サイトにおける品質からのトレーニング品質システム要素の監督を行っていただきます。

ACCOUNTABILITIES:

The core purpose of this position is to develop and maintain the site GxP Technical Learning system to build and enhance performance capability and ensure compliance with Global standards for training within GMSGQ (Global Manufacturing & Supply and Global Quality organizations) in partnership with Site Quality Systems & Compliance Lead.

The Site Learning Lead is responsible for establishing the site GxP learning plan, based on robust training needs analysis to deliver the operational competency requirements for a GXP regulated, manufacturing environment across multiple functions and for implementing the GMS learning strategy based on site needs and business objectives.

They oversee the implementation of global Training policies and GOPs (Global Operating Procedures) to ensure an efficient, effective, and compliant learning system is in place to meet site needs, in partnership with Quality Systems colleague with responsibility for GMP training oversight. Responsible for managing the continued deployment and use of LMS (Learning Management System) platforms, including administration and delivery applications.

The Site Learning Lead works with their assigned Global Learning Team Business Partner to ensure robust Learning system elements are in place and appropriate technical learning solutions are provided for site’s use. As per the Standard Site Structure, Training reports to Business Excellence at the site level, with oversight of the Training Quality System element from Quality at site.
雇用形態 正社員
応募資格 必須要件:

・GxP(ライフサイエンス組織に適用される規制やガイドライン)環境におけるパフォーマンスコンサルティング、コーチング、プログラム設計及び学習方法論を含む学習システム/プロセス開発及び実施に関するSME(Subject Matter Expert)経験

・新しい知識と基準を迅速に対応する柔軟性と能力、特にGxP技術学習システムの管理に関する規制の変化への対応力

・複雑な環境や急速に変化する環境に対応して、仕事の優先順位を調整する。トレーニングシステム及び業務プロセスの複雑な関連性及びグローバル規制の背景を理解する

・品質チームと協力して、リスクに基づくアプローチを実施し、拠点のためのトレーニング内容の決定を行う

・複雑な問題解決に関与し、多くの場合、タイトなタイムラインに関与する。すべてのソリューションにおいてコンプライアンスとビジネスリスクに焦点を当ててビジネスの問題に対処するために、適切な構造化された問題解決能力

・英語(CEFR B2・中上級レベル、TOEIC800点以上)及び日本語(日本語能力試験 N1)

・医薬品製造及び規制遵守に関する優れた知識

・科学、ライフサイエンス又は工学分野のBS(学士)

Minimum requirements:

・SME on Learning Systems/Process development and implementation, including performance consulting, coaching, program design and learning methodologies in a GxP environment.

・Flexibility and ability to assimilate new knowledge and standards quickly, particularly the Regulatory expectations on managing a GxP Technical Learning system.

・Adapt to work priorities in response to complex or rapidly changing environment. Has the context of complex operations and global regulations in relation to training systems and processes.

・Implement Risk based approached to learning decisions for site in partnership with Quality team.

・The incumbent will be involved in complex problem resolution and often tight timelines. Appropriate structured problem-solving techniques will be required to address business problems with focus on compliance and business risk in all solutions.

・English (CEFR B2 level) and Japanese (JLPT N1)

・Excellent knowledge of pharmaceutical manufacturing and regulatory compliance required.

・BS in Science, Life-science or Engineering discipline required

歓迎要件:

・製薬業界における3年以上の経験

・インストラクショナルデザイン及びLMS管理の経験

・効果的なパフォーマンスコンサルタントスキルとプロジェクト管理

・トレーニング資格(Certificate又はDiplomaレベル)、トレーニング部門の管理経験

・Over 3 years of experience in a pharmaceutical environment

・Experience in instructional design and LMS management

・Effective performance consultancy skills and project management are an advantage

・Training qualification (Certificate or Diploma level preferred), with experience in managing a training function desirable.
英語力 問わない
年収 600万 〜 1000万円
給与詳細 月額(基本給):400,000円~
<月給>
400,000円~
<昇給有無>有
<残業手当>有
<給与補足>
※年収は前職の経験を考慮の上、規定により決定します。
■昇給:原則年1回
■賞与:原則年2回
勤務地 千葉県
備考 ”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us.
global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

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