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:*
Quality

*Job Sub Function:*
Quality Assurance

*Job Category:*
People Leader

All Job Posting Locations:
Shizuoka, Japan

*Job 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:*
Supervise members responsible for checking production records, determining shipments, and handling complaints. We will secure and provide the necessary support for the reliable execution of each process, and promote continuous improvement of each process.

製造記録照査、出荷判定、苦情処理を担当するメンバーの監督を行う。各プロセスの確実な遂行に必要なサポートを確保/提供するとともに、各プロセスの継続的改善を進める。

*法規制の順守に関する責任 Regulatory Compliance Responsibilities:*
Quality Operations G Supervisors shall comply with laws and regulations related to ensuring the quality, efficacy, and safety of pharmaceuticals, medical devices, GMP Ministerial Ordinances, GCTP Ministerial Ordinances, Narcotics and Psychotropic Substances Control Act, and corporate policies and procedures.

品質オペレーション G スーパーバイザーは、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省令、GCTP省令、麻薬及び向精神薬取締法及びコーポレートポリシー、手順に従う。

*主な職務及び責務 Major Job Duties And Responsibilities:*

• Supervision and support of manufacturing record inspection and shipment judgment process

• Ensure the quality of the records while achieving the completion of the shipment decision on time and on the pre-planned date.

• Assign or support the person in charge of the manufacturing record

• Coordination and support with relevant departments and personnel
• Reporting on various KPIs

• Proposal for improvement of processes, etc., or support for promoting improvement

• Overseeing and supporting the complaint handling process. Ensure that complaints reported to the Fuji Plant are addressed in a timely manner and promptly escalated to the SLT (Senior Leadership Team) as needed.

• • Review and approve complaint-related records
• • Reporting support for reporting events and various KPIs
• • Proposal for improvement of processes, etc., or support for promoting improvement

• 製造記録照査、出荷判定プロセスの監督・サポート

• 記録の品質を担保しながら、予め計画された期日通りの出荷判定完了を達成することを確実にする。

• 製造記録の担当者割り振りまたはそのサポート

• 関連部署・担当者との調整、サポート
• 各種KPIの報告

• プロセス等の改善提案およびまたは改善推進のサポート

• 苦情対応プロセスの監督・サポート

• 富士工場に報告された苦情が適時に対応され、必要に応じて速やかにSLT(シニア・リーダーシップ・チーム)へエスカレーションされることを確実にする。

• 苦情関連記録のレビュー・承認

• 報告事象および各種KPIの報告サポート
• プロセス等の改善提案およびまたは改善推進のサポート

*職務の要件 Job Requirements*
教育/経験 Education and Experiences:

• Experience working in GxP regulated industries
• Preferably a degree in pharmacy, science, or engineering

知識、資格、及び技能 Knowledge, Qualification And Skills:

• Sufficient knowledge of quality management systems (including record checking, shipment judgment, and complaint handling)
• Communication and negotiation skills
• Critical Thinking
• Investigation and causal analysis capabilities
• Business Conversation Level English/Japanese

Core Competencies:

• Collaboration, teamwork
• Solid Credo Values
• Customer Focus
• Emphasis on EHS Rules/Procedures Compliance
• Undelayed reporting of incidents, near misses, etc.

教育/経験 Education And Experiences:

• GxP規制業界での業務経験
• 薬学、科学、工学のいずれかの学位を取得していることが望ましい

知識、資格、及び技能 Knowledge, Qualification And Skills:

• 品質マネジメントシステムに関する十分な知識(記録照査、出荷判定、苦情対応を含む)
• コミュニケーションおよび交渉能力
• 批判的思考
• 調査および原因分析能力
• ビジネス会話レベルの英語/日本語

行動特性Core Competencies:

• コラボレーション、チームワーク
• 確固たるクレドーバリュー
• 顧客重視
• EHSルール/手順遵守の重視
• インシデント、ニアミス等の遅滞なき報告

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社内公募ガイドライン

• 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。18か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。
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• 社内紹介を行う場合は、Career Hub上の"社内紹介制度の概要"の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。

*Required Skills:
Preferred Skills:*
Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management