プログラム医療機器（SaMD）開発に関わる品質管理業務★東京

OBJECTIVES/PURPOSE Provide leadership of the Quality Assurance functions for Active Pharmaceutical Ingredients (API) & Oral Solid Dosage (OSD) manufacturing, and Warehouse/Distribution. Develop and drive mid and long-term strategy and operational excellence, training/education, talent review and personnel development. Responsible for and manage all aspects of API/OSD/Warehouse Quality Assurance 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. Approve and manage site deviation investigations and assess product impact Drive API/OSD GMP adherence on the shopfloor in manufacturing areas Drive and manage the application of strategic goals Achievement of defined goals and targets in order for the Hikari plant to reach operational and compliance excellence Responsible for timely and effective communication and escalation processes to the Site Quality Head in order to raise quality and safety issues Responsible for the department expenses and department budget planning Ensures adherence to the EHS program ACCOUNTABILITIES Establish strategic goals for the API/OSD/Warehouse Quality Assurance organization in alignment with the global and site strategy, and drive action as needed to ensure timely delivery of those goals. Lead and ensure consistency in Deviation Investigation processes. Drive and manage Shop Floor QA activities, change control and validation execution. Manage warehouse support and pest control. Drive and lead Data, Digital, & Technology (DD&T) and AGILE programs in the Quality organization to be future ready Drive and lead new ways to improve and streamline current business and system processes. Identify, manage, and where appropriate, lead 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 Assurance team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge of the local and international regulatory regulations including GXP, International Council on Harmonization (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), SAP and Electronic Batch Management (EBM) 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 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 “Qualtiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

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。

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。

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.