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OBJECTIVES/PURPOSE This position will provide support to the execution of commissioning and qualification of a new Plasma manufacturing facility. This position is responsible to assess and qualify equipment, critical systems (utilities), facilities, computer systems, cleaning processes, manufacturing processes, as applicable. Primary tasks include development of protocols, coordination of commissioning and qualification activities, qualification execution, preparing final reports and assembly of final commissioning and qualification packages, and generation of project plans. Responsibilities will consist of both initial commissioning and qualification efforts as well as re-commissioning and re-qualification. Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and will be included in or support regulatory submissions, and made available as needed during internal and external regulatory/compliance audits. This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis. ACCOUNTABILITIES Applies thorough understanding of risk-based CQ, cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculums, routine project procedures, project management, and other training as appropriate. Performs a variety of projects/studies in several areas at the same time to support project timelines and budgets while maintaining quality and compliance. Supports projects that require team participation. Must demonstrate competent and effective coordination, and organizational skills. Handles routine tasks with attention to detail, timely and accurately. Participates and interfaces with cross-functional project team members (Engineering, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and other technical disciplines) representing the respective commissioning and qualification elements, as applicable, to determine commissioning and qualification strategy based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and qualification. Emphasis is on ensuring accuracy and integrity on commissioning and qualification documentation that meets regulatory guidelines and industry standards. Writes protocols and reports, executes, interprets, and evaluates commissioning and qualification documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, etc.). Utilizes Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC). Identifies gaps related to commissioning and qualification requirements and global procedures. May assist in closing compliance gaps as they are identified. Performs updates to element commissioning and qualification assessments and commissioning and qualification plans, as required. Participates, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions. Supports internal or external assessments or audits, as required. Supports process with timely closure of observations/audit items. Uses commissioning and qualification test equipment in support of commissioning and qualification activities. Performs other duties as directed by supervisor. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Must have basic experience in pharmaceutical/biotech commissioning and qualification elements, as applicable, including the writing and executing of protocols and standard operating procedures. Must have basic knowledge of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus. Leadership Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems. Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization. Decision-making and Autonomy Must demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, and problem solving Interaction Must be able to work with site and global SMEs from External Partners, Engineering, Manufacturing, Quality, Regulatory and EHS in order to design, execute and deliver to department goals and project goals. Innovation Must be able to lead and implement optimization of processes within the department or the site. Complexity Must have advanced experience and proficiency in problem analysis and resolution, a successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

職務内容 主力生産工場にて、低分子医薬品、高活性医薬品の製造に関する下記業務を担当いただき、早期上市、安定供給および生産性向上に貢献いただきます。 ・新製品の工業化に向けた化学合成プロセス検討 ・国内外の製造委託先への技術移管及び技術指導 ・工場における原薬製造のプロセス改良およびトラブル解決 ・国内外での薬事申請・照会対応、ならびに当局・販社の査察対応 ・原薬製造プロセスへの新規技術の適用

OBJECTIVES/PURPOSE: creates sustained growth through values-based impact. We operationalize our corporate philosophy to create long-term value with our corporate values. By using our core strengths and capabilities as a biopharmaceutical company, creates long-term value for patients, shareholders and society while also sustaining positive impact for our people, communities, and the planet. Our sustained growth through enduring values fuses why we exist (our purpose) with where we are going (our vision) and how we deliver on our vision (our values). Our Leadership Behaviors, anchored in our values, guide our employees on how to deliver operations consistent with our vision and purpose. We believe that everyone in leader regardless of their role and we expect our people to focus on four behaviors: Think Strategically, Inspire Others, Deliver Priorities and Elevate Capabilities as they contribute to our vision and purpose. Our imperatives and priorities direct where must focus to deliver on our vision and purpose. Informed by a materiality assessment, these imperatives and priorities are framed under patient-people-planet powered by data, digital and technology with corporate philosophy metrics that hold us accountable for making progress on these focus areas. With that in mind, this role will help further sustained growth to: • Establish internal control systems of ESG data to protect corporate reputation • Empower people in this organization who create and perform long-term value creation to build, promote and protect corporate reputation ACCOUNTABILITIES: 1. Be a leader and empower team and people building knowledge around sustainability and ESG, and what it will take for sustainability as an enabler for us to bring long-term value creation to life. 2. Demonstrate the leadership as a member of the Sustainability LT with Head of Global Sustainability and Head of Sustainability Network Management based out of Boston reporting directly to Head of Global Sustainability and co-own the team performance and capability building, drive team culture and embrace life-long learning mindset. 3. Be accountable for internal control system of ESG data by partnering with responsible corporate functions based in Tokyo and Boston, which meet forthcoming requirements (e.g. Annual Integrated Report, ESG indices, and non-financial metrics in financial reportings) and leverage existing operating models 4. Drive ownership/leadership of internal stakeholders to shape conversations of sustainability/ESG to activate build sustainability ambassadors foundation (e.g. voluntary employee engagement group) to promote corporate reputation 5. Supervise outside stakeholders’s engagement and work collaboratively with Boston-based team members to build trust with prioritized outside stakeholders given the variety of outside stakeholders (e.g. institutional stakeholders, shareholders, financial advisory, pharma/non-pharma organizations, regulatory) . 6. Provide outside-in data-driven ESG insights that can be great impact for innovation and sustainability stories to strengthen favorability and familiarity 7. Partner with senor leaders (TET-1 and -2) to clarify our message towards sustainability through leadership communication to set up their aspiration in the future CORE ELEMENTS RELATED TO THIS ROLE: • Inclusive leadership for people 1. Effective collaboration: Empower others, pay attention to diversity of thinking and psychological safety, and focus on team cohesion 2. Curiosity about others/Inspire others/think about others: Demonstrate an open mindset and deep curiosity about others, listen without judgment, and demonstrate empathy to understand those around 3. Humility: Be modest about capabilities of self and others, accept mistakes and encourage to learn, and create the space for others to contribute. 4. Cultural intelligence: Be attentive to others’ cultures and adjust style as required for effective teamwork given taking a global role with partnering so many stakeholders with different back-grounds and cultures • Values-based governance/decision-making for the organization 1. Commit to process-driven and transparent governance and operating model 2. Enhance agile decision-making to fit for purpose by having conitinued and trusted partnership with key stakeholders fully engaged 3. Strong problem solving skills : critical thinking, process information, creativity that allows to break down difficulties and challenges into smaller, easier and getting ahead to more mana-geable points • Flexibility and resilience mindset for sustainability and ESG 1. Fully capable of understanding the enterprise agenda and its requirements, which is still evol-ving given uncertain ESG world outside. Need capability to catch outside ESG perspective and bring right key takekaways to sustainability strategy 2. Be flexible to review and adjust priorities in line with our sustainability/ESG agenda and capable to orchestrate all the components that can help leaders decide right directions towards long-term value-creation 3. Thrive in ambiguity and ongoing operations towards getting directions : linked with #1, need to think about the optimal approach given current situation and information that leaders are having by being mindful of our organizational vision and purpose with enduring values and being aspira-tional to aim stretching areas we are capable to explore.

募集部門の紹介 国内最大工場で、医薬品原薬・医薬品を製造しています。その品質管理を行う部門で原料の受け入れから出荷まで一貫した試験を行っています。今回、応募している部門は、その中でも試験開発、実施している試験のコンプライアンスの確保を行っており、一般的な試験業務とは一線を画しています。試験に関する技術を取得されたい方は是非チャレンジしてください。工場はグローバル化が進んでおり、グローバル基準のGMPを経験したい、海外の方と業務をしてみたいという方にも是非。 工場の所在地は山口県光市です。自然豊かで、気候の穏やかな地域で、工場は瀬戸内海の海岸沿いに立地しています。山にも近く、自然を愛する方、自然の中でゆっくり過ごしたい方には絶好の場所です。 職務内容 分析法の開発、分析技術移管、申請書作成、局方改訂時のアセスメント、変更管理、逸脱調査など。 小グループのリーダー若しくはリーダー候補。

職務内容 以下の品質保証業務を担当頂きます。 開発プロジェクトのGMP遵守状況の監視 製造方法・試験方法の承認 治験薬出荷（製造記録照査を含む） 治験薬製造における変更管理 治験薬製造における逸脱・OOS/OOT・苦情の調査 サプライヤーに対するGMP監査ならびに品質契約の締結 継続的な品質システムの改善

職務内容 生物学的製剤の充填作業およびそれに伴う以下のような周辺関連業務 製造工程や設備のバリデーション／クオリフィケーション ワクチン製造に関わるドキュメントの作成 当局の査察の対応 生産トラブルの対応

職務内容 医薬品（ワクチン）の業務及び付帯関連業務 ・原材料・資材の在庫管理 ・秤量作業と緩衝液の調整 ・硝子製品の取り扱い ・洗浄・滅菌用設備の取り扱い ・アイソレーターを用いた無菌充填作業 ・製造設備の操作 ・設備メンテナンス計画の立案など

職務内容 ・CMCチームの目標および関連申請書類の承認を計画通りに達成する。 ・多様化する医薬品ポートフォリオのCMCライフサイクルマネジメント活動にプロジェクトマネジメントの専門知識を提供する。 ・高度にマトリックス化された環境において、部門横断的なチームを管理し、プロジェクト目標の達成を確実にする。 勤務地 大阪工場 ※一部リモートワーク可

職務内容 音声およびビデオ会議のグローバルサービスチームのテクノロジースペシャリストとして、日本時間のプラットフォームの維持管理やプロジェクト推進や、サービスマネジメントを行います。バックエンドのクラウドサービスに加えて、会議室内に設置されるAV機器を適切に制御し、円滑な会議が可能なようサポートを提供します。 主な責任範囲 会議室AV機器会議インフラストラクチャを適切に維持管理する（主に日本国内） グローバルサービスチームと連携し、システム更新等を日本で円滑に推進する イベントサポートの提供（パートナーと協業したサポート体制の管理、自身のハンズオンサポート双方を含む） 会議インフラに関するテクノロジートレーニングやユーザーガイドを提供する 社内ITSMプロセスに準拠しインシデント、リクエスト、変更管理を行う 日本のビジネスユーザーの要望や相談窓口となり、必要な対応を進める

募集部門の紹介 国内最大工場で、医薬品原薬・医薬品を製造しています。その品質管理を行う部門で原料の受け入れから出荷まで一貫した試験を行っています。今回、応募している部門は、試験部門で試験を実施するのみでなく、チームリーダーを担うことができる方を求めています。将来的には一つのグループのマネージャーにチャレンジしてみたいという方に是非応募していただきたいポジションです。工場はグローバル化が進んでおり、グローバル基準のGMPを経験したい、海外の方と業務をしてみたいという方にも是非。 工場の所在地は山口県光市です。自然豊かで、気候の穏やかな地域で、工場は瀬戸内海の海岸沿いに立地しています。山にも近く、自然を愛する方、自然の中でゆっくり過ごしたい方には絶好の場所です。 職務内容 品質試験の実施、および品質試験のチームを率いる小グループのリーダー若しくはリーダー候補。

OBJECTIVES/PURPOSE Deputy Site Quality Head. Provide leadership of Quality Control functions. Develop and drive mid and longterm strategy and operational excellence, training/education, talent review and personnel development Accountable for and manage all aspects of Quality Control at the facility, ensuring that quality systems, laboratory compliance and related functions are in place and meet current Good Manufacturing Practices (cGMP), other regulatory quality standards and requirements. Direct and ensure that laboratory operations are effective and carried out on schedule. Direct and ensure GMP compliant laboratory operations on site. Managing application of strategic goals Achievement of defined goals and targets in order to drive the Hikari plant to reach operational and compliance excellence ACCOUNTABILITIES Support Site Quality Head as deputy. Establish strategic goals for the Quality Control organization in alignment with the global and site strategy, and drive actions as needed to ensure timely delivery of goals. Lead and manage consistency in laboratory operations and data review process among Quality Control. Drive and lead new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements. Responsible for the coaching, training, and development of the Quality Control team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or 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 both Japanese and 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), and SAP 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 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. Interaction Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or 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 both Japanese and 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), and SAP 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 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. Interaction Interacts with the Site Quality Head and all site functions (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 “Qualitiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assusrance, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

Job Description Please note that this job requires business level Japanese language command not only in speaking, but also in business writing and reading. Are you looking for a patient-focused, innovation-driven company that will inspire you? Be empowered to take charge of your career and future. Join us as a Title in our Location office. global, R&D-driven biopharmaceutical company. We have an unwavering dedication to put people first and we live our values of ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our 235-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Futurefor people worldwide through leading innovation in medicine. Here, you will be a vital contributor to our inspiring, bold mission: The Power Platform Engineer combines Microsoft Power Apps and Power Automate technical skills with business process knowledge to craft low code solutions used to enable digital transformation . The Engineer consults with business teams to recommend process solutions based on business requirements, working closely with both end users and the larger Digital Workplace team. Key Responsibilities Platform Engineering A detailed professional skilled in PowerApps and Power Automate solution design and development in order to support client business needs. Use a strong sense of logical process to translate business requirements into technical steps, as well as make recommendations for process improvement. Act as the liaison between clients, colleagues, and business partners in delivering solutions. Able to recommend the right combination of Power Platform tools for each scenario, understanding when it is beneficial to use Dataverse, SharePoint, or other sources as part of a solution. Work in an agile environment and be responsive to changes in platform features. Willing and able to work as part of a global team.

職務内容・ミッション 試験分析機器におけるData Integrity改善活動を行う。（マネジメント兼担当者） -マイルストーン策定、進捗管理、レビュー -関係チームと協力しての問題を解決 -チーム内の取りまとめ -計測機器のCAPA立案、実行 -PJの定例会議へ参加する。 ターゲットとなる業界や企業 医薬品製造業（GMP）、分析機器メーカー 仕事のやりがい 試験分析機器のData Integrityを確保することでサイトとしてあるべき姿に近づき、高品質の医薬品を市場に提供できる体制が構築できる。 身につくスキル・経験 ・各国レギュレーションの専門知識 ・プラズマ領域の品質管理 ・クロスファンクショナルコミュニケーション能力 ・オーナーシップ 部門・部署・グループ紹介 GQ成田製薬品質部　試験グループは製品完成前までのあらゆる検査を行い、品質基準を満たしているかをチェックし、市場に製品を出す時点の品質管理に責任を持ちます。 私たちは日常業務をこなすことだけでなく、GQビジョンのもと、チームの強化や個々のスキルアップにも尽力するべく、患者さんに貢献できることを第一に考えた組織の体制を構築している道半ばです。品質に対する信頼と社会貢献を軸に、ビジネスバリューを一緒に創作できる仲間を求めています。

職務内容 医薬品等（低分子医薬品、バイオ医薬品、再生医療等製品、医療機器等）の日本における承認取得後のCMC薬事に関連する下記業務 申請戦略・申請計画のCMCパートについて立案・遂行 当局相談に係る戦略策定及び遂行 製造販売承認申請業務（CMCパート） 導入案件のCMC薬事関連の評価

OBJECTIVES/PURPOSE Leads team that ensures uninterrupted delivery of Safe, Sustainable, Resilient, Reliable, Compliant Plant Utilities (GMP and non-GMP) and Infrastructure to the manufacturing plant Support Global Sustainability Program objectives through the development of long range carbon/energy/water/waste reduction plans and deliver project portfolio of engineering solutions to meet the Site’s Environmental Sustainability goals and objectives ACCOUNTABILITIES Responsible for all black utility functions in the Plant: Utilities operations, Utilities Maintenance, Sustainability Engineering and Plant Engineering Accountable owner of site carbon project portfolio and long-range plan (MRP) in partnership with the Site EHS Sustainability Lead Monitor and report the Site’s carbon, energy, and water consumptions, identify trends and measure the effectiveness of sustainability engineering projects Leads, develops, and trains high performing utilities & facilities function and staff Member of the site engineering leadership team Owner for site utilities and facilities operations and maintenance budget and long-term asset management plan Primary site point-of-contact for internal and external carbon assessments Delivers site carbon operating mechanisms, goals/KPIs, and communication plan DIMENSIONS AND ASPECTS Interaction EHS Sustainability Lead, Utilities/Facilities Operations, Plant Engineering, Automation, Contractors, Consultants, CAPS Community of Practice

OBJECTIVES: Sets a forward looking “People” agenda for the Global Corporate Affairs (GCA) and Corporate Strategy (CS) global functions and directs the deployment and embedment of a people agenda across the Functions The “People” agenda will encompass an integrated global approach to organization capabilities & effectiveness, engagement & belonging, lifelong learning, talent management & development, talent acquisition and people analytics & insights Trusted partner to GCA and CS TET (Executive Team) and an influential member of their respective Leadership Team (LT.) Expected to co-evolve the organization strategy, with a deep understanding GCA including external dynamics and trends. Brings together HR leads from ach business unit/function to shape and embed GCA and CS people priorities. Key contributor to both the Corporate Function HR Leadership team and Global HR Function who elevates capabilities within and across HR ACCOUNTABILITIES: Deliver an exceptional people experience within the functions so everyone can fulfil their potential and enable mission Drive an integrated global approach to organization capabilities & effectiveness, engagement & belonging, lifelong learning, talent management & development, talent acquisition, and people analytics & insights Set a short- and long-term forward-looking people agenda for the functions Shape TET and TET-1 leadership team (LT) member thinking and the direction of their function Active role in ensuring LTs’ effectiveness. Support both executive and team development. Elevate the organization’s performance Develop, deploy and embed talent management and learning programs within these functions. Foster a culture of continuous learning Drive organization effectiveness, proactively set an agenda that spans mindset, process, role and org design, capabilities and measurement/KPIs Steward of the employee experience. Develop and direct the deployment of initiatives that make these functions a great place to work and creates a competitive advantage. Ensure ongoing feedback loops and multi-way dialogue between employees, LT, COEIs, People Solutions, etc. Oversee cyclical global talent management processes such as succession/talent planning, performance management and compensation Manage labor and employee relations within these Functions. Mitigate risk for company, ensure objectivity, consistency, sound judgment and compliance Ensure talent acquisition and total rewards practices are competitive and aligned with the Function’s needs Deliver high quality people insights. Course correct as required and inspire step change solutions for the Function Engage in collaborative relationships with HR Partners (HPs) and HRBLs, HR COEIs, TBS People Solutions and other Corporate Functions like Finance, Ethics & Compliance and Legal. Partner to create solutions that make an impact when deployed and embedded within the Functions As part of the Corporate Function HR Leadership team, help shape the overall strategy for Corporate Function HR. Identify patterns and root cause solutions that are best for the Function and enterprise Lead a matrixed HR community of practice comprised of HR Partners and HRBLs who support extended Communication and Public Affairs LTs. Create an environment which inspires people to do their best and is aligned to the Company’s values. Elevate HR capabilities Lead and participate in Global HR projects as required. Apply knowledge of how these Functions work and contemporary external best practices to co-create solutions that deliver results