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R＆D Quality Laboratory Oversight （Associate Director）
年収：1100万 ～ 1700万
採用企業案件
武田薬品工業株式会社
-
- 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 | R＆D Quality Laboratory Oversight （Associate Director） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
OBJECTIVES/PURPOSE Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities. Ensure implementation and execution of data integrity and quality system standards in internal and external laboratories. Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness. Lead key quality initiatives and investigations related to laboratory operations. ACCOUNTABILITIES Provide quality oversight for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline. Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses. Ensure appropriate implementation of ALCOA+ principles and data integrity controls in laboratory systems and workflows. Lead or support laboratory-related investigations and inspections, ensuring timely root cause analysis and sustainable CAPA. Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other Quality functions. Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA). Contribute to the development and improvement of global procedures, standards, and quality frameworks for laboratory oversight. Monitor quality performance trends and proactively escalate compliance risks or improvement opportunities. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Strong understanding of GxP regulations, analytical methods, and laboratory operations across modalities (small molecules, biologics required; cell/gene therapy, plasma, or vaccines a plus). Demonstrated application of data integrity principles and computerized system controls in laboratory environments. Experience with internal and external laboratories, technical agreements, and audit preparation. Proficiency in quality risk management, deviation handling, and CAPA effectiveness. Leadership Supports strategic goals of the R&D GMP Quality organization. Coaches junior team members or cross-functional partners on quality principles. Effectively communicates quality expectations and analytical requirements. Influences decision-making in cross-functional settings and supports change management efforts. Decision-making and Autonomy Exercises judgment in resolving laboratory-related quality events and compliance issues. Makes independent decisions within the scope of analytical QA responsibilities. Provides recommendations for quality risk mitigation and system improvements. Interaction Collaborates with Analytical Development, QC, Manufacturing, Regulatory, and QA teams. Interfaces with external laboratories and CMOs as required. Participates in regulatory inspections, audits, and governance meetings. Innovation Contributes to process improvements and implementation of digital solutions. Promotes knowledge sharing and continuous improvement culture within the team. Identifies new tools or practices to enhance laboratory compliance and efficiency. Complexity Supports laboratory oversight across a range of modalities and global sites. Navigates matrixed organizational structures and diverse cultural and regulatory landscapes. Balances scientific, compliance, and business needs in decision-making. |
| 応募資格 |
【必須（MUST）】 Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field. Preffered advance degree (MS/PhD)7+ years of relevant industry experience in quality oversight of laboratory operations Demonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspections Strong interpersonal, project management, and problem-solving skills Ability to operate in a global matrix environment and manage competing priorities |
| 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 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/11/20 |
| 求人番号 | 6153876 |
採用企業情報
- 武田薬品工業株式会社
-
- 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
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です