ClinicalQualityAssurance

■仕事内容 【OBJECTIVES/PURPOSE】 ・Provides leadership and guidance to the CQA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable. ・Contributes to the design and implementation of Takeda’s risk-based GCP audit and compliance oversight activities. ・Monitors effectiveness of GCP processes through risk-based audits and GCP compliance activities and provide actionable data to Senior Management based on identified compliance issues and trends. ・Oversees and provides necessary support for the GCP components of egulatory Inspections. 【ACCOUNTABILITIES】 ・Provides leadership and guidance to the CQA Program Managers to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable. ・Provides ongoing development of the CQA Program Managers, including staff selection, work assignments, goal completion, development plan review, and performance management, as applicable. ・Establishes strong partnership/relationship with business stakeholders ・Develops and implements a strategic audit plan in collaboration with Global CQA Leaders. ・Ensures audit observation, report, and rating consistency for assigned area of responsibility. Ensures activities are conducted and reports written according to applicable SOPs and regulations. ・Acts as a quality resource with expertise in regulations relating to GCP, ICH guidelines, and Development Operations SOPs. ・Responsible for the CQA due diligence for new compounds/alliances for Quality, in collaboration with senior management in QA. ・Manages Therapeutic Area Programs of a highly complex nature and/or high-risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple “niche” vendors ・Monitors and interprets compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to CQA management for immediate and long-term resolution across Takeda R&D. ・Provides appropriate risk analysis for key stakeholders to make critical decisions. ・Represents Takeda R&D during GCP regulatory inspections assuring management that responses are timely and appropriate to maintain good standing with regulatory agencies. ・Coaches and educates external sites and cross functional Takeda R&D staff in regulatory inspection readiness activities. 【CORE ELEMENTS RELATED TO THIS ROLE】 ・Provides team members with timely, constructive feedback, coaching and support to help them recognize and take action on their strengths and development needs in unprecedented, complicated and challenging projects such as new disease areas and new therapies. 【DIMENSIONS AND ASPECTS】 Technical/Functional (Line) Expertise ・Advanced knowledge and experiences in drug development process, and its horizontal expansion to unprecedented, complicated and challenging projects such as new disease areas and new therapies. ・Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development. ・Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity. ・Strong technical writing skills; able to write quality positions, audit reports, and procedures. Leadership ・Provides strategic leadership to the Clinical Quality Assurance (CQA) Program Managers even in case of never experienced therapeutic areas or new modalities, and partner with key stakeholders that are integral to clinical development activities, as applicable. ・Provides expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program cross-functional teams and leadership, especially in unprecedented, complicated and challenging projects such as new disease areas and new therapies. ・Provides opportunities to develop others’ technical/functional skills and behaviors. ・Negotiates and influences without authority in a matrix environment. Interaction ・Collaborates with and achieves results through R&D operational functions and suppliers of outsourced services in order to build win-win relationships with broad ranges of stakeholders. ・Engages diverse team members with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems. ・Fluent in written and spoken English to interact with the global stakeholders. Innovation ・Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines. ・As deputy for a CQA Director (based on delegation), motivates Japan CQA employees to innovate on past practices. ・In collaboration with a CQA Director, reveals the root of the problem and to improve the current existing processes/concepts by encouraging Japan CQA employees. ・In collaboration with a CQA Director, establishes the environment where employees grow through challenging assignments so they may realize their full potential. Complexity ・Superior attention to detail and ability to analyze complex data under the unprecedented, more complicated and challenging circumstances. ・In case of challenging situations such as new therapeutic areas or new modalities, sets the direction and creates solutions even if there are no answers or hints based on own experiences. ・Deep insight of how to encourage others from the perspective of people management in challenging projects such as new therapeutic areas or new modalities. Decision-making and Autonomy ・Focuses people on key priorities and guides them to achieve their goals and helps employees grow through challenging assignments so they may realize their full potential with full autonomy in collaboration with a CQA Director. ・As deputy for a CQA Director (based on delegation), creates and implements regional strategy in line with global strategic objectives and in collaboration with R&D Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with local regulations, Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements. ・As deputy for a CQA Director (based on delegation), provides strategic direction and manages health authority GCP sponsor and investigator routine and pre-approval inspection readiness, conducts, and follow-ups activities for development programs in Japan, ensuring that GCP inspection commitments are fulfilled on time. 【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】 《必須》 ・BA/BS degree required; advanced degree preferred. ・Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry. ・Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience. ・Minimum 5 years leading teams in a matrix cross-functional team. ・Languages: Japanese (native level), English (business level). 【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） ・Allowances: Commutation, Housing, Overtime Work etc. ・Salary Increase: Annually, Bonus Payment: Twice a year ・Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45 ・Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year) ・Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave. ・Flexible Work Styles: Flextime, Telework ・Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc. 【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: ※下記でも勤務あり。<グローバル本社>東京都中央区日本橋本町2-1-1

年俸1200万円～1500万円 ■給与 年俸 12,000,000円~15,000,000円 想定年収1,200万円〜1,500万円程度 ・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 医療管理 ■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02月26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