Head of Quality Control (Senior Director)

OBJECTIVES/PURPOSE Provide leadership of Quality Systems & Compliance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel development Managing aspects of Quality Systems & Compliance of drug substances and drug products at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), other regulatory quality standards and requirements. ACCOUNTABILITIES Manages the Quality Systems & Compliance organization making sure the site goals are cascaded into the department. Ensure that quality related computerized systems including TrackWise and DMS/LMS are effectively implemented across the site. Ensure that change control process is in place and all changes are appropriately assessed, necessary actions are taken and the changes are implemented. Maintain validation programs and review and approve validation documents. Manage and host overseas/domestic regulatory inspections or audits. Create documents associated with manufacturing license and communicate with regulatory authorities. Generate APQR associated with products in Narita and approve them. Organize Quality Management Review and monitor and control Quality KPI/Metrics. Investigate cause of customer complaints and create investigation reports. Maintain supplier management programs and qualify suppliers/service providers. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines. Knowledge in Plasma Derived Therapeutic processes including sterile operations and packaging operations. 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 Change Control/Complaint/Inspection and SAP systems. 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 Narita 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 Head and all site functions (Business Excellence, EHS, HR, Finance, IT, Manufacturing, Engineering and Supply Chain) 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”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assurance, Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

【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

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.

医薬品の品質保証業務における以下業務のうち、複数を担って頂く予定です。 ショップフロアQA（現場作業を直接監視・監督） バッチレコードを含む書類の照査 逸脱調査 業務範囲は、成田工場の生産部門及び試験部門であり、対象製品は無菌注射剤（血漿分画製剤）です。グローバル化対応も含みます。