募集要項
- 募集背景
- 組織強化のため。
- 仕事内容
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多数の革新的な製品を有する外資系バイオ製薬会社の品質保証部門で、品質保証【シニアマネージャー～アソシエイトディレクター】職を募集いたします！・Deputy of Quality Assurance Officer
製薬業界での品質保証のご経験が豊富な方を求めております。
・Manages the operations of several areas of Quality Management System within commercial QA including responsibility for work methods, operations excellence, managing costs.
・Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
・Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
・Implements and maintains programs and processes to ensure high-quality products and compliance with GQP/GMP/GDP.
・Manages the training department, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
・Oversight of embedded Document Coordinator program and qualification of Document Coordinators
・Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
・Responsible for final release of manufactured products
- 応募資格
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- 必須
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・10+ years of QA relevant experience in the pharmaceutical industry and a Master of Science.
・5+ years of QA relevant experience with Quality Management System
・Experience with Electronic Document Management Systems or other GXP applications.
・Experience in Project Management for Launch, site transfer and analytical transfer.
・Experience in GMP compliance inspections, FMA and Conformity check.
・Experience in analytical, process chemistry and/or formulation development.
・Excellent Japanese and English business communication skills.
・Demonstrates in-depth knowledge of PMD Act (薬機法), GMP, GQP and GDP.
・Demonstrates knowledge of Information Systems Technology, understanding of Computer System Validation (CSV) including current electronic records and signature requirements.
- 歓迎
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・Experience in Biologics is preferred.
・Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is preferred.
・Knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is preferred.
・Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred.
- フィットする人物像
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・Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
・Demonstrates resourcefulness, critical thinking, and objectivity to integrate the quality philosophy into the daily operations of the organization
・Navigates the gray, is adaptable, flexible, and open to change point of view to reach win-win solutions
・Uses existing resources and seeks new ways to improve performance of people, processes, and systems.
- 雇用形態
- 正社員
- ポジション・役割
- 品質保証（Commercial QA）【シニアマネージャー～アソシエイトディレクター】
- 勤務地
- 東京本社
- 勤務時間
- 9:00～18:00 フレックス制度あり
- 年収・給与
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1000万円～1200万円（目安） 年俸制
※インセンティブボーナス含む。別途、RSUあり。
※別途、該当者には単身赴任手当等あり。
- 待遇・福利厚生
- 通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、退職金制度、確定拠出年金制度、ベネフィットステーション
- 休日休暇
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完全週休2日制（休日は土日祝日）
年間有給休暇12日～20日（下限日数は、入社直後の付与日数となります）
年間休日日数125日
年末年始休暇、グローバル休暇、有給休暇は初年度は入社日により最大12日付与、傷病休暇
- 選考プロセス
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【選考プロセス】書類選考⇒面接（3～4回）⇒内定
