At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
People LeaderAll Job Posting Locations:
Shizuoka, JapanJob Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at
職務概要Position Summary:
- 本職務記述書は、品質システムGに適用する。 This Job Description applies to the position of Quality System Group at JPKK, Fuji Plant.
- GMP/GCTPにおける品質システム、コンプライアンスの関わる業務を自ら実施し、また、グループメンバーが担当する業務の監督を行う。 Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group member.
法規制の順守に関する責任 Regulatory Compliance Responsibilities:
- 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律、GMP/GCTP及びコーポレートポリシー、手順に従う。Comply with Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP, all corporate policies and procedure.
主な職務及び主な責任 Major Job Duties and Responsibilities:
- マネージャーとしてグループ運営、ピープルマネジメント、予算管理などを行う。 As a manager, responsible for group operations, people management, and budget control.
- 逸脱管理責任者として、逸脱/CAPAレコードのレビュー・承認、重大な逸脱に関して調査の深堀の推進もしくはリード、関連ミーティングの運営、出荷スケジュールとの調整、他の逸脱承認者との業務調整などを行う。 As the Deviation Management Responsible, review and approve deviation/CAPA records, drive or lead in-depth investigations for critical deviations, facilitate related meetings, coordinate with shipment schedules, and align with other deviation approvers as needed.
- エスカレーションが生じた場合は、エスカレーション準備のリード、資料作成、議事録作成などを行う。 In the event of an escalation, lead the preparation process, create presentation materials, and prepare meeting minutes.
- 査察対応 Audit management.
- 業務改善 Implement Kaizen.
- グループメンバーが担当するGMP/GCTP活動、業態管理などの監督 Supervise member' GMP/GCTP activities and license management activities.
- トラブルシューティング、逸脱調査、エスカレーションの準備、スタッフのサポート Trouble shooting and investigation of deviation, prepare escalation and support member.
- メンバーのキャリア形成のサポート Supporting individual career development.
- 新しい取り組みのリードもしくはサポート Lead or support new initiatives.
職務の要件 Job Requirement
教育/経験 Education and Experiences:
- 薬学、理化学または生物学の学位を修了していることが望ましい。 Degree in Pharmacy, physics and chemistry or biology is preferable.
- 製薬業界における品質管理、品質保証、規制遵守などの分野での5年以上の経験が望ましい。 More than 5 years of experience in various areas such as Quality control, Quality Assurance, Regulatory Compliance in pharmaceutical industry is desirable.
知識、資格、及び技能 Knowledge, Qualification and Skills:
- GMP/GQP/QMS品質システムに精通している。Knowledgeable of GMP/GQP/QMS quality systems.
- ビジネスレベルの英語力を有していることが望ましい。Business-level English proficiency
- ソフトウエアアプリケーションを効果的に使用できる能力を有していること。例: MSオフィス、Trackwise Have an ability to effectively use software applications. Ex. MS office, Trackwise
行動特性 Core Competencies:
- ピープルマネジメント及びリーダーシップ People management skill and Leadership
- 高いコミュニケーション能力 Excellent communication
- 戦略的思考及び意志決定 Strategic Thinking and Decision-Making
- プロジェクトマネージメント Project Management skills
- 問題解決能力 problem-solving skills
- 顧客フォーカス Customer focus
- 財務・ビジネス知識・業務効率化 Financial & Business Acumen and Operational Efficiency
#LI-Onsite
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Required Skills:
Preferred Skills:
Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management-
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