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東京都の品質管理の求人220件応募資格・募集要項・仕事内容を見る
Manager, External Quality Assurance
- 給与
- 記載なし
- 勤務地
- 東京都中央区
- 休日
- 完全週休２日制（土曜・日曜）
- 雇用形態
- 正社員
どんな仕事かAIによる生成
CMO Managementを支えるGMPおよび関連システム・プロセスを担当し、外部CMOに対する品質面の窓口として、アステラスの品質基準や規制要件への適合を支援します。CMOの品質システム評価、逸脱・品質問題の解決、監査・査察、サプライヤー評価、品質リスク管理などを行います。品質上の重要事項やリコール対応、品質関連文書の管理にも携わります。
この求人に応募
応募資格
必須
- Science Graduate or equivalent professional qualification and/or proven expertise
- Pharma sector experience
- Proven compliance expertise; to understand and comply with industry laws and relevant regulations.
- Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
- Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders.
- Fluent in written and verbal business English
歓迎
- Previous experience in pharmaceutical Quality Assurance, CMO oversight or in-plant GMP pharmaceutical manufacturing
募集要項最終確認 11/13
- 職種
- 品質管理
- 雇用形態
- Employment Class:** Permanent期間の定めなし試用期間原則なし
- 役職
- Manager
- 給与
- 記載なし
- 給与の詳細
- ①基本給：当人の経歴・技術・技能等を考慮して決定②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給有り有り
- 手当
- 裁量労働手当50,000～100,000円住宅手当通勤手当
- 勤務地
- 東京都中央区 アステラス製薬 日本橋事業所 本社
- 働き方
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
- 勤務時間
- 8:45～17:45（月～木）、8:45～16:00（金）、企画業務型裁量労働制またはスーパーフレックス制裁量労働制の場合、所定労働時間を働いたものとみなす
- 休日・休暇
- 完全週休２日制（土曜・日曜）祝日5月1日夏季年末年始年次有給休暇育児休業制度介護休業制度
- 福利厚生
- 共済会制度社宅制度持株会制度財形貯蓄制度
- 社会保険
- 雇用保険、労災保険、厚生年金、健康保険
- 業務の変更の範囲
- 会社内での全ての業務
- 就業場所の変更の範囲
- 会社の定める事業場および自宅
- 選考の流れ
- 書類選考 → 1次面接 → 最終面接※変更の可能性もございますので、予めご了承下さい。
- 掲載日
- 2026/11/13 20:23（1日前）
- 最終確認
- 2026/11/13 20:23（1日前）
仕事内容
募集の背景 / Purpose & Scope
- This position is responsible for all aspects of GMP and related systems and processes supporting CMO Management. This person will act as a Quality Ambassador focusing and influencing Contract Manufacturing Organizations (CMO’s) to comply with Astellas quality standards, policies and industry cGMP requirements. This position will serve as the main point of contact between Astellas and external CMO’s for quality issues and has oversight of Supplier Evaluation Programs, Quality Agreements, Change Management, CMO Annual Product Reviews and Quality Risk Management. This position communicates potential risks to line manager for appropriate action in collaboration with colleagues and affiliates.
- Responsible for, managing the following quality systems for Astellas CMO products: Deviation Management (including CAPA), Change Control, SQIM, Risk Evaluation Committee, Audits, Stability, Annual Product Review, Complaints, Supplier Evaluation, Quality Business Review Meetings and Regulatory Intelligence
CMO QA Oversight:
- Oversees the GMP activities and processes for Astellas commercial drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by CMOs, supported by line management.
- Provide QA support for regulatory agency inspections at CMOs as necessary.
- Participate in CMO Business Review Meetings.
Assessment of the effectiveness/compliance of the Quality System in CMOs
- Facilitates the resolution of all deviations, non-conformances and other batch related quality issues with the CMO to ensure product compliance.
- Employs a Risk Management approach to evaluate Quality issues to ensure that drug substances, intermediates, and in-process and finished drug products manufactured for Astellas by CMOs conform to all regulatory and Astellas product specifications.
- Participates in the CMO Evaluation Program for CMO products as required. Develops and distributes formal reports in a collaborative manner. Cooperates with Supply Chain, Purchasing, and Quality Systems groups to maintain a list of approved CMOs.
- Identifies and communicates major GMP compliance issues to line Management. Participates in formal corrective/preventive action plans using a Risk Based approach.
- If required may support in the audit and inspection of CMOs by Health Authorities, external consultant and Global Quality Systems. Support special audit of the plants and contract manufacturer, as required.
Compliance:
- Embed Compliance Culture across all Regions of the business ensuring Integrity in Action is actively applied in all initiatives.
- Ensure the Product QA Function strictly adopts a culture of ethics and compliance; leading by example and appropriately challenging non-compliance.
- Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).
Surveillance of Significant Quality Issues (SQIs) and resultant investigations in the Region.
- Assures CMO compliance with Astellas corporate policies, Global Procedures and Guidelines, SOPs and regulatory agency standards.
- Supports QA assessments of SQIs and REC activities, under the guidance of line manager. Maintains related records and tracking systems.
- Support the coordination of recalls, as well as notifications to regulatory agencies.
QA Activities
- Supports the Continuous Improvement programme. Develops and maintains effective relationships with internal and external stakeholders which may include regional Astellas entities.
- Participation in cross functional teams supporting commercial products.
- Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., SOPs, WPDs, Forms, etc.) as necessary
- Monitoring and periodical review of CMO Management Quality System and participation in Management Review activities.
- Participates in a for-cause audit of the plants and contract manufacturer, as required.
- Evaluate product quality reviews and address questions and comments raised by marketing authorisation holders.
- Other such duties as may be reasonably required by the business.
変更の範囲
- 会社内での全ての業務
就業環境に関する要件 / Specific Physical or Environmental Requirements
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
- Some travel is expected for this role, mostly in region
この求人は、アステラス製薬株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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