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R－105264 Associate Director, Product Quality ＆ Quality Information （PQQI）

年収：応相談

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部署・役職名	R－105264 Associate Director, Product Quality ＆ Quality Information （PQQI）
職種	QA（品質保証）
業種	医薬品メーカー CRO
勤務地	兵庫県
仕事内容	職務名Job Title Associate Director, Product Quality & Quality Information (PQQI) 部署名Department Product Quality & Quality Information (PQQI) 職位Position Title Associate Director/Director QA, Product Quality & Quality Information (PQQI) 直属上長の職位Supervisor Title Exec. Director, Quality Assurance スコープScope The Associate Director, Product Quality & Quality Information (PQQI) sets the strategy and leads the PQQI function for Lilly Japan, with direct accountability for both the Product Quality and Quality Information teams and their respective staff, including the QI Team Leader. The role ensures compliant, effective, and efficient operations across the full product lifecycle — spanning pre-market through post-launch phases — with particular emphasis on GQP-governed activities, product launches, and quality information management processes. The Associate Director is accountable for maintaining robust GQP operations, driving operational excellence, and fostering cross-functional alignment in a dynamic and rapidly evolving business environment. 職能、任務及びタスクSpecific functions, duties or tasks Leadership & Team Management Determine the strategic direction and execution plan of the PQQI team aligned with the overall Japan QA strategy set by the Japan affiliate quality leader to ensure success of ELJ 2030 and Accelerate Reach and Scale at the affiliate. Partnering with the Japan affiliate quality leader (Hinseki), determine, execute, and continuously improve PQQI strategy for today and future business needs Lead the PQQI team, directly managing both the PQ function and the QI Leader (M1), who reports directly to this role. Serve as the single accountable leader for all GQP-related operations across both teams. Drive organizational effectiveness by integrating PQ and QI functions, exploiting synergies to improve quality outcomes, speed, and operational efficiency. Lead the team through a high period of growth and a rapidly changing business environment, model adaptability, clear prioritization, and resilience. Manage all people-related responsibilities including performance management, talent development, resource allocation, diversity and inclusion, and recognition for direct reports and the extended PQQI team. Ensure team members are appropriately qualified and trained; maintain and continuously improve training curriculum maps covering GQP, QMS, GMP, and Japan regulatory requirements. Foster a culture of accountability, continuous improvement, and high performance; support Q-unit members in maintaining a healthy work-life balance. GQP Compliance & Quality Management Accountable for all GQP and QI operations within the PQQI team, both pre- and post-product launch, including product release, complaint quality management, quality information reporting, and sourcing site oversight. Ensure the operational execution of PAI and GMP inspection readiness and support processes at all manufacturing, packaging, and supplying sites for Japan marketed products. Work with the P4 Inspection Readiness/Support Process Owner and GQP SME to ensure effective and efficient PAI and GMP inspection processes. Establish, implement, and maintain GQP/QMS and GDP standards and SOPs in accordance with the Pharmaceutical and Medical Device Act (PMD Act) and applicable corporate standards (LQS, GQS, CQP). Manage Marketing Affiliate quality activities per GQS181 and applicable GSOPs; oversee and maintain agreements with sourcing sites; liaise with ELJ QA and sourcing site QA to uphold importing product quality standards. Create and maintain robust systems for final product release to market; review and approve proposed changes and deviations in accordance with GQP requirements. Serve as Product Quality Representative (PQR) per JQA00-01, “Quality Manual.” Lead JCS and JSC activities. Process Excellence & Operational Efficiency Drive the design and implementation of clear, simplified, and efficient processes across the PQQI team, with well-defined roles and responsibilities and strong cross-functional alignment. Continuously improve QI complaint handling processes and PQQI quality systems; establish, monitor, and act on team metrics and corrective actions to ensure delivery against commitments. Monitor ELJ quality and regulatory activities; maintain and improve communication between Japan and sourcing sites; influence business partner processes to improve compliance and efficiency. Product Quality & Quality Information Ensure the PQQI team is launch-ready for new products, line extensions, and process or product changes; provide timely quality feedback to project teams to support pre-launch quality preparedness. Oversee the provision of accurate, timely, and trustworthy quality reports to customers through APRC and QI, support call center with technical and quality information. Periodically review and communicate quality and performance metrics and trends; propose product, process, and service improvements to appropriate functions. Build and sustain strong working relationships with ELJ QA, call center, manufacturing and packaging site quality teams, ELJ regulatory, and other internal and external partners. Maintain awareness of and ensure alignment to the latest corporate policies, procedures, and local regulations; propagate “Japan Quality” standards to overseas sourcing sites. 職務認定に必要とされる最低限の要件 [学歴、職務経験、トレーニング、認証]The minimum qualification requirements: Education, Experience, Training, Certification Leadership Competencies (Critical for this Role) Demonstrated ability to set strategy, lead, develop, and inspire multi-functional teams, proven track record as a people leader in a regulated pharmaceutical environment. Proven ability to drive organizational integration and exploit synergies across functions; experience leading teams through high-growth or rapid change. Strong process design and simplification skills; demonstrated ability to define clear roles and responsibilities and remove ambiguity in complex cross-functional environments. Deep understanding of GQP/QMS/GMP/GDP regulations and applicable Lilly corporate standards (LQS, GQS, CQP, GSOPs); ability to interpret and apply regulatory requirements with practical business judgment and quality risk management principles. Strong cross-functional influencing and stakeholder management skills (including global teams and stakeholders); capability to build and sustain productive relationships with internal and external partners including sourcing sites, call center, regulatory, and senior leadership. Strong critical thinking and problem-solving capability; ability to lead teams to root cause resolution based on sound technical and scientific understanding. Demonstrated ability to coach and develop direct reports including 1st line leaders; experience building team capability and succession depth. Qualifications Bachelor’s degree or higher in pharmacy, chemistry, biology, engineering, or related health science field; advanced degree preferred. Substantial experience (minimum 5 years) in GQP/QMS/GMP/GDP quality operations within the pharmaceutical industry, with progressive leadership responsibility. 弊社では社員のウェルビーイングと生産性の観点から、自宅最寄り駅から勤務地までの通勤距離が90㎞以内かつ公共交通機関の所要時間*が90分以内の範囲を、通勤可能上限としています。それよりも遠方にお住まいの場合は、通勤可能な範囲にご転居いただくことを原則としております（借上社宅の貸与あり）。車両通勤を認める場合においても、上記を適用します。従事すべき業務の変更の範囲：当社業務全般就業場所の変更の範囲：将来のキャリアの一環として、東京支社・西神工場・海外オフィスでの勤務をする場合もありうる
労働条件	＜処遇＞【給与】　当社規定により優遇します。【諸手当】住宅手当、通勤交通費など【昇給】有り【賞与】個人業績結果及び会社業績結果に基づく業績変動賞与を支給する。　支給時期は、営業職は9月および翌年3月に支給、非営業職は翌年3月に支給。【勤務時間】8：45～17：30 【時間外手当】なし【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。（ただし、一斉休憩を除く）1日の必要最低労働時間：4時間（半日休暇時は2時間）　一斉休憩：12時～13時【在宅勤務制度】有【受動喫煙対策】あり　就業場所　全面禁煙【休日休暇】完全週休2日制（土・日曜日）、祝日、クリスマス、年末年始・夏期　*年間休日125日、年次有給休暇、慶弔等【保険】雇用・労災・健康・厚生年金保険【福利厚生】住宅援助制度、借上社宅制度、リリーグループ補償制度（医療費・歯科医療費補助　制度等）【定年制】有（60歳）【継続雇用制度】：有（65歳まで）【有給休暇】年途中で入社した社員に対する年次有給休暇は、次の入社月の区分に従い入社翌月1日に付与される。入社日にかかわらず、その年の12月31日をもって、勤続年数が1年経過したものとみなし、翌年1月1日に翌年度の年次有給休暇が付与される。　入社月　 1-6月　　 7月　　 8月　　 9月　　 10月　　11月　　12月　付与日数　 10 　　　5 　　　4　　　 3 　　　 2 　　　 1 　　　 0 【試用期間】 6か月間　　試用期間中での賃金の違いはありません。
応募資格	【必須（MUST）】 Demonstrated ability to set strategy, lead, develop, and inspire multi-functional teams, proven track record as a people leader in a regulated pharmaceutical environment. Proven ability to drive organizational integration and exploit synergies across functions; experience leading teams through high-growth or rapid change. Strong process design and simplification skills; demonstrated ability to define clear roles and responsibilities and remove ambiguity in complex cross-functional environments. Deep understanding of GQP/QMS/GMP/GDP regulations and applicable Lilly corporate standards (LQS, GQS, CQP, GSOPs); ability to interpret and apply regulatory requirements with practical business judgment and quality risk management principles. 【歓迎（WANT）】 Strong oral and written English and Japanese communication skills. Demonstrated leadership experience with multi-functional teams. Experience in Marketing Affiliate quality operations and sourcing site management; knowledge of Lilly marketed products, compounds in development, manufacturing processes, and complaint investigations preferred. Experience managing through organizational change and business growth; proven ability to deliver results in dynamic, evolving environments.
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	2026/05/11
求人番号	8246361

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