Head of Quality Control (Senior Director)

ACCOUNTABILITIES The role is accountable for the overall quality strategy and quality management system of commer-cial vaccines operations and supplies in Japan. The Head of commercial Vaccines Quality is respon-sible to design, deploy, monitor and improve the quality management system and for compliance to current Good Manufacturing/Distribution & Laboratory Practices and compliance to global standards and overall Hikari Site Standards. The Head of commercial Vaccines Quality partners with the GMS site quality head and aligns on site quality strategy, a harmonized cross-plant quality philosophy & joint quality initiatives and main-tains good day to day collaboration between the 2 site quality organizations. Ensures that new/revised quality system requirements are deployed to the site timely. Ensures execution leads for Quality-owned business processes are established who work with the business process owner to continually execute compliantly & improve on site processes. Responsible for Japan vaccine quality performance, continuous improvement and Q-metrics (KPI) monitoring to ensure global and site targets are achieved, met and countermeasures are in place when applicable. Responsible for Quality Control testing and sampling for commercial vaccines (Bulk Drug Substance and Drug Product (BDS, DP)) and partners with other laboratories or external laboratories for testing that is performed on behalf of vaccines quality (eg. Microbiology, Environmental Moni-toring, Raw Materials) Responsible to establish the appropriate quality oversight for outsourced activities such as testing as well as quality assurance review of site validation activities. Development and refinement of groups’ specific quality systems and procedures. Committed to continuous improvement and responsible to proactively mitigate current and future risks to maintain an effective operation to support business needs. Living values and fostering a Quality Culture culture of trust and and speak up culture within the team. Assuring appropriate GMP and QA systems training of Quality personnel and continuously develop team´s capabilities and expertise. Accountable for quality oversight of site quality management systems (CAPAs, Change Controls, Deviations, Formal Risk Management, facility/equipment/process qualification) Responsible for site specific QMR management and gathering of APQR data. Align with GMSGQ team and provide QA support for electronic system integration: LIMS, Trackwise, SAP etc. Responsible for vaccine batch disposition decisions taking into account all relevant information and escalation processes. Oversight of execution of product disposition (drug substance). Responsible to ensure sufficient and adequate quality oversight of vaccines manufacturing and distribution processes. Preparing for/ supporting/ leading internal and health authority regulatory inspections and third-party audits, including communicating with and providing information to regulatory submissions or bodies. Responsible for timely updates of site achievements and challenges to management with a focus on quality compliance, operations performance, staff performance and productivity/training, staff development, continuous improvements, key projects support and identification and resolving obstacles to maintain a highly effective and productive functional group. Responsible for management of cross-plant quality issues and timely escalation of vaccines related issues within the global VBU organization. Responsible for budget planning and managing expenses and for timely hiring, training and devel-opment of qualified staff to ensure effective execution of roles and responsibilities, GMP compli-ance, and attainment of operational and development goals. DIMENSIONS AND ASPECTS Knowledge and experience of Biologics manufacturing Knowledge and understanding of Health Regulations applicable to local and other markets supplied Knowledge and understanding of industry, scientific and regulatory trends, established prod-ucts portfolio and market conditions to evolve regulatory and quality profile Strong analytical and problem-solving skills (preferably Lean & 6 Sigma background). Leadership Ability to lead a Quality organization of internal manufacturing with full accountability for all aspects of performance of respective site (Customer Service Levels, GMP compliance, EHS compliance, Opex Cost Savings, lab transformation, People Culture & Change) Ability to build a customer & patient-centered, best in class organization, develop diverse talent and elevate organizational performance Ability to make and recommend Quality decisions impacting Market Actions etc., enabling to deliver on its commitment to put patients first and build trust with society Decision-making and Autonomy An active member of Site Leadership teams and vaccines quality teams Responsible for decision making that balances progress on global initiatives with local priorities Responsible for Vaccines Quality governance (Quality Councils / Management reviews) Responsible for active and timely Incident notifications and associated escalation activities DOA limits to be defined in line with new TMAP Interaction Key stakeholders include: global & Japan VBU, Global Manufacturing and Suplly site Quality, Procurement, Supply Chain, Regulatory Affairs. Local Board of Health Agency, National Control Laboratory

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】 下記の主な業務を担当していただきます。 ・現場作業の監視・監督 ・逸脱調査 ・製造記録や試験記録などの照査 ・バリデーション ・変更管理 ・査察準備及び対応業務

再生医療等製品の製造受託サービスおよび創薬を手掛ける当社において、再生医療・細胞医薬品の品質管理のスタッフとしてご活躍いただきます。 【具体的には】 ・再生医療等製品における品質管理に関わる業務および分析法開発業務（バリデーション含む） ・外部研究機関や製薬会社からの受注や創薬に関する品質管理業務。