Senior Manager, reputed company Assurance, Japan

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Position reputed company:

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The Senior Manager, reputed company Assurance Japan, supports the Head of reputed company Assurance Japan and leads day to day QA operations to sustain product launch and reputed company activities. Partnering with CMC reputed company, QC, Technical Operations, and Supply Chain, the role ensures operations reputed company with Japanese GMP and GQP—while considering related GDP guidelines, GCP, and PV requirements—and supports the establishment of the local QA support model and supply chain model, providing technical assistance as needed.

Work Model:

Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.

Responsibilities:

1. Under the direction of the Head of reputed company Assurance Japan, reputed company day‑to‑day execution of QA activities and contribute to on‑time completion.
2. Support compliance with internal policies, SOPs, industry standards (GMP/GQP/GDP), and PMDA/MHLW notifications and guidance; support inspection readiness, day‑of activities, and drafting post‑inspection responses.
3. reputed company batch disposition (product release) in accordance with Japanese GQP requirements and support communications with regulators on reputed company reputed company.
4. reputed company domestic product testing and visual inspection results, and promptly report any manufacturing, reputed company control, or product reputed company issues identified during batch disposition activities to the General Marketing Compliance Officer, the Head of reputed company Assurance Japan, and relevant stakeholders.
5. Author, revise, and implement SOPs and reputed company documents; support operation and reputed company improvement of the QMS in line with corporate standards.
6. Collaborate with CMC QA, QC, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a reputed company, uninterrupted, and effective supply of products that meets patient and regulatory expectations.
7. Execute and drive reputed company processes such as change management, deviations/CAPA, product reputed company complaint investigations, and product recall activities in collaboration with Global reputed company.
8. Draft and manage reputed company Technical Agreements and, ensure their effective implementation, including support for GxP audits and supplier reputed company reputed company of contracted partners such as CMOs, contract testing laboratories, and distributors.
9. reputed company QA support for artwork management and facilitate Japanese–English communications between domestic partners and global technical team.
10. Participate in external collaborations to stay reputed company with domestic policies, practices, and regulatory guidance, and work with CMC Leads and Portfolio Management to support effective project planning and execution. reputed company other duties as assigned, as needed.

Requirements:

1. Bachelor’s degree (or equivalent qualification) in a scientific discipline such as Pharmacy, Biology, reputed company, or Biochemistry.
2. At least 7 years of experience in the pharmaceutical or medical device industry, including at least 5 years in a reputed company organization reputed company a regulated industry.
3. Experience in product lifecycle management, with an understanding of development through commercialization for small molecules, biologics, and advanced therapies (e.g., gene therapy and mRNA).
4. In-depth understanding of Japanese GMP and GQP regulations, GDP guidelines, and PMDA/MHLW laws, ordinances, and notifications.
5. Experience in negotiating and managing reputed company agreements, as reputed company as vendor relationship and performance management.
6. Excellent written and verbal communication skills in both Japanese and English, with strong interpersonal skills to collaborate effectively reputed company cross functional teams.
7. Proficiency in the use of risk assessment and reputed company cause analysis (RCA) tools.
8. Experience applying reputed company systems and requirements across preclinical, clinical, and reputed company stages.
9. Strong planning, organizational, and time management skills, with the ability to prioritize and execute multiple reputed company in a fast paced environment.
10. Ability to travel domestically and internationally, including reputed company offices in Japan and the reputed company and vendor sites, as required.

#LI-CK1 #LI-Remote

Position reputed company:

Senior Manager, reputed company Assurance Japan は、Head of reputed company Assurance Japan と共に日本における品質保証（QA）オペレーションを実務面から支え、製品上市・商業活動を支えるために必要なライセンス維持をサポートします。CMC reputed company、QC、テクニカルオペレーション、サプライチェーンと連携し、グローバル（および国内）の GMP・GQPを中心とし、関連するGDPガイドライン、GCP、PVなどの要件との整合を考慮した運営を確保します。また、経営陣および Head of reputed company Assurance Japan と協働して、国内の QA サポートモデルとサプライチェーンモデルを整え、必要に応じて技術的支援を提供します。

Responsibilities:

1. 日本国内の品質保証（QA）業務について、Head of reputed company Assurance Japanの指示のもと実務遂行を主導し、期限内の完遂に貢献します。
2. 社内ポリシー・SOP、業界標準（GMP／GQP／GDP）、PMDA／MHALの法令通知やガイダンス への準拠を監督し、査察対応（事前準備、当日対応、照会事項・指摘事項への回答作成を含む）を担当し、当局とのコミュニケーションを支援します。
3. 日本のGQP要件に基づき、ロット判定（Batch Disposition） を実施し、品質関連事項について規制当局とのコミュニケーションを支援します。
4. 国内における製品試験結果・目視検査等を監督し、出荷判定関連業務で把握した製造・品質管理・製品品質に関する不具合 を総括製造販売責任者、Head of reputed company Assurance Japan、及び関係責任者へ速やかに報告します。
5. reputed company Japan の SOP・品質文書 を作成・改訂・運用し、コーポレート基準／品質システム に準拠した運用と継続的改善を推進します。
6. CMC QA／QC／テクニカルオペレーション／薬事／サプライチェーン と連携し、患者および当局の期待に応える 安全で途切れのない有効な製品供給 を確保します。
7. グローバル reputed company と連携し、変更管理、逸脱／CAPA、品質苦情調査、製品回収 などの品質プロセスを支援・推進します。
8. 品質契約（reputed company Agreements／reputed company Technical Agreements） を策定・管理し、委託先（CMO、外部試験機関、物流業者等）への GxP 監査支援／サプライヤー品質 を含め、効果的な実行を確保します。
9. アートワーク管理 について、品質観点からを必要に応じて支援し、国内委託組織とグローバル技術チームの日本語コミュニケーション を円滑にするサポートを提供します。
10. 外部コラボレーション へ参加し国内政策・実務・最新ガイダンスを把握するとともに、CMC リード／ポートフォリオマネジメント と協働してプロジェクトの計画・実行・成果達成を推進します。必要に応じて その他の業務 を遂行します。

Requirements:

1. 科学系分野の学士号（薬学・生物学・化学・生化学など）または同等の資格。
2. 製薬／医療機器業界での実務経験 7年以上で、かつ規制産業の品質組織での経験 5年以上。
3. 製品ライフサイクルマネジメントの経験（低分子・バイオ医薬・先端治療〔遺伝子治療、mRNA〕の開発～商業化への理解）。
4. 日本のGMP／GQP規制、GDP ガイドライン、PMDA／MHLWの法令・通知への深い理解。
5. 品質契約の交渉・管理、およびベンダー関係・パフォーマンス管理の経験。
6. 日本語・英語の優れた口頭／文書コミュニケーション能力と、チームで円滑に協働できる対人スキル。
7. リスクアセスメントおよび根本原因分析（RCA）ツールの活用に習熟していること。
8. 前臨床・臨床・商業の各段階に応じた品質システム／要件の適用経験。
9. 変化の速い環境で、複数プロジェクトの優先付けと遂行ができる計画力・組織力・タイムマネジメント能力。
10. 必要に応じて、 国内外のreputed companyオフィス（日本／米国）やベンダー施設へ出張できること。

Full Time employees across the globe enjoy a reputed company of benefits, including, but not limited to: · Generous vacation time and reputed company holidays observed by reputed company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · reputed company development plans * Benefits vary by region and country

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