GDP輸出品質管理マネージャー

■仕事内容 【OBJECTIVES/PURPOSE】 ・Ensure compliant GDP export execution?by providing operational Quality oversight and expert guidance across export/transportation activities, maintaining inspection readiness and robust documentation. ・Lead risk and quality event management?by identifying and mitigating distribution risks, translating QMS requirements into practice, and driving deviations/CAPA and change control for export lanes, providers, and processes. ・Oversee external partners (especially central-contracted distributors)?through qualification and performance monitoring, effective Quality Agreements, and strong cross-functional collaboration across Supply Chain, Site Quality, LOC Quality, and project teams. ・As deputy RP responsible Eligible to perform all the duties and have all rights applicable to the Deputy Responsible Person in Singapore as per HSA requirements 【ACCOUNTABILITIES】 ・Provide operational GDP Quality oversight for export execution?across shipment preparation, handover, transportation, and delivery, ensuring activities meet applicable GDP regulations and Takeda Quality standards. ・Serve as the Quality SME for export and transportation?(including cold chain where applicable), advising on packaging/ship-to configurations, monitoring strategy, handling instructions, security controls, and lane suitability. ・Lead risk identification, assessment, and mitigation?for export distribution (lanes, carriers, forwarders, 3PLs, distributors), ensuring risks are documented, owned, controlled, and periodically reviewed in line with governance expectations. ・Oversee deviation/event management for export distribution?(e.g., temperature excursions, delays, damages, misroutes, seal breaches), ensuring timely triage, investigation support, documented Quality impact assessment, and effective CAPA implementation. ・Drive change control for export GDP scope, ensuring changes to lanes, logistics partners, distributors, packaging solutions, and monitoring processes are assessed and implemented with appropriate Quality review, evidence, and approvals. ・Deliver GDP oversight of contracted distributors?(central Takeda contracts), including distributor qualification/onboarding, Quality Agreement content and maintenance, periodic performance review, escalation management, and ensuring continued compliance with Takeda expectations. ・Ensure compliance with Good Manufacturing Practice and Good Distribution Practice Standards in Singapore ・The company has given authority to the Responsible Person to perform the required activities as per local regulations which include: ensuring that an effective quality system is implemented and maintained that meets GDP standard; focusing on the management of authorized activities and the accuracy and quality of records; ensuring that initial and continuous training prorammes are implemented and maintained; coordinating and promptly performing any recall operations for therapeutic products; ensuring that relevant customer complaints are dealt with effectively; ensuring that suppliers and customers are legally approved or authorized to enable lawful supply of therapeutic products; approving any subcontracted activities which may impact on GDP; ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place; keeping appropriate records of any delegated duties; deciding on the final disposition of returned, rejected, recalled or counterfeit products; approving any returns to saleable stock; ensuring that any additional requirements imposed on certain products by national legislation are adhered to, e.g. controlled drugs. 【CORE ELEMENTS RELATED TO THIS ROLE】 ・Maintain strong cross-functional collaboration?with Global Supply Chain, Trade Compliance, Site Quality Organizations, GDC/RDC-related LOC Quality, and Takeda project teams to resolve issues, support initiatives, and ensure aligned decision-making. ・Experience overseeing?global export lanes, cold chain distribution, and complex third-party networks. ・Experience with distributor qualification/oversight programs and supplier management. ・Familiarity with global GDP frameworks (e.g., EU GDP guidelines) and practical application across regions. ・Ability to interpret data trends (excursions, lane performance, partner KPIs) to drive risk-based decisions 【DIMENSIONS AND ASPECTS】 Technical/Functional (Line) Expertise ・Demonstrated experience in?GDP Quality?within pharmaceutical distribution, logistics, or supply chain (typically 5+ years depending on internal leveling). ・Strong working knowledge of GDP expectations for?transportation,?outsourced distribution, and?quality agreements. ・Experience with deviation management, investigations, CAPA, and audit readiness in a regulated environment. ・Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints) Leadership ・Ability to collaborate and partner well regionally & cross-functionally with Takeda stakeholder groups and RDCs ・Strong communication skills with ability to influence cross-functional stakeholders and external partners. ・Ability to drive change by influence Decision-making and Autonomy ・Quality approval/endorsement for GDP controls impacting export lanes and distribution models (per Takeda governance). ・Role-specific accountability for Quality oversight of selected distributors and logistics provider Interaction ・Internal:?Supply Chain Governance, Global/Regional Quality, Logistics/Transportation teams, Trade Compliance, Planning, Customer Service, Site QA/QP & RP ・External:?3PLs, freight forwarders, carriers, packaging and monitoring suppliers, contracted distributors. Innovation ・Understanding of quality and regulatory requirements and trends related to warehousing and distribution across the global regions. 【従事すべき業務の変更の範囲】 It is possible the job scope may change at the company’s discretion. 【就業場所変更の範囲】 It is possible the department and workplace may change at the company’s discretion. 【事業内容】 医薬品等の研究開発・製造・販売・輸出入 優れた医薬品の創出を通じて人々の健康と医療の未来に貢献する タケダは、世界中のあらゆる人々のニーズに貢献しています。 タケダイズムを通じ、社会やタケダの医薬品を必要とする方々からの信頼を得ています。 タケダイズム（誠実：公正・正直・不屈）と Patient：患者さん中心 Trust：社会との信頼関係構築、Reputation：レピュテーションの向上 Business：事業の発展、の順に重視する考え方は、常に高い水準を追求する、正しい行動に取り組む という私たちの働き方に深く根付いています。 グローバル企業として タケダでは世界の70を超える国と地域で、約30,000人の従業員が、世界中の人々の健やかで明るい未来に貢献しています。 また、新興国と先進国の市場特性に合わせ、競争力の高い製品を構築。 世界約80ヶ国に事業基盤を有するグルーバル製薬企業として更なる発展を目指しています。 【応募要件】 《EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS》 ・Scientific Degree (BSc, MSc) ・Minimum 10 years experience in in the pharmaceutical industry including Quality Assurance, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)? ・Strong attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/ records etc.) ・Prior experience managing external GMP/GDP suppliers ・Fluent in written and spoken English 《Core Competencies / Skills》 ・Risk-based decision making with strong Quality mindset ・Pragmatic operational execution and ownership ・Partner management and governance ・Clear documentation and inspection readiness discipline ・Continuous improvement and problem-solving 《Deliver on Takeda Leadership behaviours》 ・Think Strategically ・Inspire others ・Deliver? priorities ・Elevate Capabilities 【休日休暇】 年間休日123日程度 ・週休二日制（土日） ・祝日 ・メーデー ・年末年始 ・年次有給休暇 ・特別有給休暇 ・傷病休暇、ファミリーサポート休暇 ・産前産後休暇、育児休暇、子の看護休暇、介護休暇 ・ボランティア休暇 【待遇・福利厚生】 ・社会保険完備 ・独身寮・社宅 ・財産形成：従業員持株会、財形貯蓄、住宅融資、企業年金制度 ・保養所（全国各地） ・人材育成支援制度 ・テレワーク勤務制導入（対象社員） 【受動喫煙防止について】 屋内全面禁煙 【雇用形態】 正社員 雇用期間の定め：無 【募集企業情報】 会社設立日 1925年1月29日 なお本求人は職業紹介事業者であるリクルーティング・パートナーズ株式会社 人材紹介事業部による紹介案件です。 ■仕事の特徴 経験者・有資格者歓迎

〒540-8645大阪府大阪市中央区道修町4-1-1 武田薬品工業株式会社 ■勤務先 武田薬品工業株式会社 〒540-8645 大阪府 大阪市中央区道修町4-1-1 ※アクセス情報: ※下記の勤務もあり。<グローバル本社>東京都中央区日本橋本町2-1-1

年俸750万円～1000万円 ■給与 年俸 7,500,000円~10,000,000円 想定年収750万円〜1,000万円程度 ・諸手当：通勤交通費、借家補助費、勤務時間外手当など ・昇給：原則年1回 ・賞与: 原則年2回 固定残業代の有無：なし

固定時間制 ■勤務時間 就業時間9:00〜17:30 フレックスタイム制度あり ■労働時間 実働時間：1日あたり7時間45分 平均勤務日数：1ヶ月あたり20日 平均残業時間： 平均所定労働時間：1ヶ月あたり155時間

■休日休暇 有給休暇 冬期休暇 介護休暇 育児休暇 産前産後休暇 土日祝休み 年間休日120日以上 週休2日制

【保険制度】 ・雇用保険 ・労災保険 ・健康保険 ・厚生年金 ■待遇・福利厚生 昇給あり 社会保険あり 賞与あり 資格取得支援制度 寮・社宅・住宅手当あり

試用期間なし

■職種 製品品質保証管理・検査業務 ■勤務形態 固定労働時間制 ■雇用期間の定め 本文中に記載 ■職業紹介事業者 リクルーティング・パートナーズ株式会社 ■更新日 2026年04月20日

• 年間休日120日以上
• 介護休暇あり
• 賞与あり
• 育休あり
• 土日祝休み