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【光工場】Group Manager, Vaccine Sterility Assurance Group

年収：1100万～ 1600万

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部署・役職名	【光工場】Group Manager, Vaccine Sterility Assurance Group
職種	QC（品質管理） QA（品質保証）
業種	医薬品メーカー
勤務地	山口県
仕事内容	About the role: The Associate Director Microbiology is responsible for managing and performing scientific research, development, and testing of new products, manufacturing processes, and raw materials. This role aims to enhance the understanding and manipulation of microorganism behaviors, contributing to the development of innovative solutions and ensuring the highest quality standards in our products. How you will contribute: * Apply advanced microbiology techniques to understand and manipulate microorganism behaviors * Conduct biochemical assays independently, applying knowledge to complex situations * Utilize molecular biology tools like PCR and DNA sequencing effectively in research contexts * Implement CAPA strategies, identifying issues and formulating effective preventive measures * Perform chemical analyses with precision, contributing to the development and evaluation of substances * Maintain aseptic environments in laboratory settings to ensure uncontaminated experiments * Lead teams effectively, setting objectives and delegating tasks to achieve research goals Skills and qualifications: * Applies advanced microbiology techniques to understand and manipulate microorganism behaviors. * Conducts biochemical assays independently, applying knowledge to complex situations with minimal guidance. * Utilizes molecular biology tools like PCR and DNA sequencing effectively in research contexts. * Implements CAPA strategies adeptly, identifying issues and formulating effective preventive measures. * Performs chemical analyses with precision, contributing to the development and evaluation of substances. * Maintains aseptic environments in laboratory settings to ensure uncontaminated experiments. * Demonstrates expertise in biochemistry, enhancing understanding of biological processes in product development. * Leads teams effectively, setting objectives and delegating tasks to achieve research goals. * Manages projects efficiently, ensuring alignment with organizational goals and timely completion. * Ensures compliance with Good Laboratory Practice standards in research activities. * Communicates complex scientific data clearly and effectively, adapting to various audiences. * Oversees quality control processes, ensuring products meet rigorous standards. As a leader of a functional area or organization, you will set objectives, delegate tasks, and ensure operational success, with reviews by senior management. You will also help shape company policies, tackle complex problems, and meet budgets and schedules. Your responsibilities include managing projects, influencing organizational goals, maintaining frequent communication with peers and customers, and leading teams and projects, serving as a best practice/quality resource. ■OBJECTIVES/PURPOSE Provide leadership of sterility assurance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel develop-ment Managing Sterility Assurance Group operations for vaccine manufacturing area Managing a scientific strategy development of aseptic environmental monitoring Ensure GMP and regulatory compliance including Pharmacopoeias and related guidelines (GMP ministerial guidance in Japan, ICH Q guidelines and so on.) Enhance the collaboration among related functions in the site and organization Achievement of defined plan with KPIs in order to drive the VBU and Hikari plant to reach operational and compliance excellence ■ACCOUNTABILITIES Provide the vision of responsible group and achieve related KPIs Ensure talent development based on appropriate quality conversations and communications Manage and create the current and mid term plan of resources for responsible group Oversight environment monitoring activities and ensure the environmental condition in manufacturing area meeting current GMP requirements Clarify the concepts and requirements of sterility assurance in vaccine operations and ensure sterility assurance of vaccine products Promote the collaboration work with the other function in Vaccine Quality, VBU, Hikari site and GQ organization Maintain inspection / audit readiness with appropriate GMP compliance ■DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise： Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines. (GMP ministerial guidance in Japan, ICH Q guidelines and M guidelines and so on.) Knowledge in sterile product, aseptic process, sterilization process, parenteral technology, biologics and combination products. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in Japanese Business level verbal and written communication skills in English Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Information Management systems preferred. Leadership： Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy： Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Agility to act Interaction： Interacts with the Vaccine Quality Japan Head and all relevant site functions (e.g. VBU-Japan Manufacturing, GQ, EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) Interacts with Global Quality functions and Regulatory Affairs, as well as local and global regulators. Interacts frequently with subordinates, functional peers, and the Senior Leadership Team. Innovation： Strong knowledge of Quality Risk Management principles. Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products. Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business. Lead and engage employees by initiatives of “Quality Culture” to drive continuous improvements. Complexity： Key stakeholders include but not limited to: VBU-Japan Manufacturing, Vaccine testing, Quality Control, Quality Assurance, Hikari Site Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
労働条件	■待遇・諸手当：通勤交通費、借家補助費など・昇給：原則年1回、賞与：原則年2回・勤務時間：本社（大阪市中央区・東京都中央区）9:00～17:30、工場（山口県光市・大阪市淀川区）8:00～16:45 、（千葉県成田市）8:30～17:15 、研究所（神奈川県藤沢市）9:00～17:45 ・休日：土曜、日曜、祝日、メーデー、年末年始など（年間123日程度）・休暇：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・働き方関連制度：フレックスタイム制、テレワーク勤務制導入（対象社員）・福利厚生：社会保険制度、退職金・企業年金制度、従業員持株制度等 ■労働条件に関する重要事項業務内容については入社後に会社の定める業務への変更もあり得ます。配属先および就業場所に関しては、入社後に会社の定める部署および就業場所への変更もあり得ます。 ■Locations 山口県
応募資格	【必須（MUST）】・Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline. ・At least 5 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality Control; understanding of the requirements for manufacturing, ・plant utilities, computer systems and project management. ・In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines. ・Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law) ・Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.) ・Business level of English skill is necessary (both verbal and written) 【歓迎（WANT）】・License for pharmacist ・Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. ・Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.
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管理職・マネージャーフレックスタイム
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	2026/01/13
求人番号	6519831

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