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  5.  >  Global Data Digital ＆ Technology （DD＆T） （東京ベース・ハイブリッド勤務）

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【武田薬品】Risk ＆ Compliance Specialist, Global Data Digital ＆ Technology （DD＆T） （東京ベース・ハイブリッド勤務）

年収：800万 ～ 1000万

採用企業案件

採用企業

武田薬品工業株式会社

  • 東京都

    • 資本金1,676,200百万円
    • 会社規模5001人以上
  • 医薬品メーカー
部署・役職名 【武田薬品】Risk ＆ Compliance Specialist, Global Data Digital ＆ Technology （DD＆T） （東京ベース・ハイブリッド勤務）
職種
業種
勤務地
仕事内容 About the role:

Risk & Compliance Specialist is responsible for overseeing computer systems validation programs across the organization within a regulated cGMP environment. This individual collaborates with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implements risk-based validation strategies, and oversees validation and testing activities using modern tools and methodologies. This role supports Takeda's mission by delivering high-quality, compliant solutions while guiding and developing validation team members to achieve departmental goals.


How you will contribute:

1. Develop, initiate, and oversee risk-based validation strategies and procedures to ensure compliance with regulatory standards and industry best practices for IT systems and processes.

2. Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues.

3. Establish, monitor, and report Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) for validation effectiveness and compliance.

4. Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions.

5. Provide leadership in advancing validation frameworks and documentation processes, aligning with business goals and compliance requirements.

6. Guide and mentor validation team members to develop their expertise and ensure the successful delivery of projects in adherence to Takeda’s compliance standards.

7. Continuously improve validation processes by adopting innovative tools and methodologies to enhance efficiency and effectiveness while maintaining regulatory compliance.

8. Coordinate with cross-functional teams to ensure a seamless approach to validation and compliance initiatives enterprise-wide.


Skills and qualifications:

1. Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc)

2. Working knowledge of manufacturing IT systems like LIMS,MES, TrackWise,etc.

3. Experience working with virtual teams on a global basis

4. In depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to Manufacturing IT systems

5. Ability to lead teams in the correct interpretation of regulations

6. Good oral and written communications skills, business acumen with problem solving and analytical skills


Key Responsibilities:

1. Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

2. Execute validation tests and compile comprehensive phase reports.
Perform risk analysis and mitigation planning for IT systems, laboratory systems, and manufacturing systems.

3. Evaluate and address validation risks associated with system changes, updates, or implementations.

4. Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards.

5. Act as a subject matter expert during validation-related phases of system upgrades or deployments.

6. Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices.

7. Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented.

8. Partner with cross-functional teams to establish validation requirements and ensure project goals align with business and regulatory needs.

9. Provide expertise and guidance on validation processes to project teams and stakeholders.

10. Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices.

11. Serve as a go-to expert for validation-related challenges and initiatives.
Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems.

12. Continuously integrate improvements and ensure alignment with regulatory guidelines.
応募資格

【必須（MUST）】

Qualifications:

1. 8-10 years of experience in a similar role

2. Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).

3. Proven experience infrastructure qualification and computer system validation.

4. In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).

5. Familiarity with cloud qualification practices (nice to have).

6. Strong analytical and problem-solving skills.

7. Excellent communication and teamwork abilities.

8. Attention to detail and a commitment to quality.

9. Professional/business level in both English and Japanese will be key to success in the role.

アピールポイント 自社サービス・製品あり 日系グローバル企業 女性管理職実績あり 上場企業 従業員数1000人以上 創立30年以上 年間休日120日以上 産休・育休取得実績あり ストックオプション制度あり 教育・研修制度充実 資格支援制度充実 マネジメント業務なし 完全土日休み フレックスタイム
リモートワーク

可

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受動喫煙対策

屋内禁煙
更新日 2025/10/21
求人番号 5939371

採用企業情報

武田薬品工業株式会社
  • 武田薬品工業株式会社

  • 東京都

    • 資本金1,676,200百万円
    • 会社規模5001人以上
  • 医薬品メーカー

  • 会社概要

    【設立】1925年1月29日
    【代表者】クリストフ・ウェバー
    【資本金】1兆6,762億円 ※2022年3月末時点
    【従業員数】5,149名 ※2022年3月末時点
    【本社所在地】東京都中央区日本橋本町二丁目1番1号
    【その他事業所】大阪、神奈川、山口、千葉、京都

    【事業内容】医薬品等の研究開発・製造・販売・輸出入

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