求人名 Manager, Inspection Management
勤務地 Nihonbashi, Tokyo
事業部 品質保証
雇用形態 正社員
仕事内容
【募集の背景 / Purpose & Scope】
This role is responsible for the development, implementation, and maintenance of excellence in Inspection Administration.
Responsible for developing Inspection readiness and preparation strategies, procedures, and program management for all global inspection related activities.
Ensures global implementation and consistency of processes and procedures with the respective QA functional areas. This includes the establishment of regulatory agency inspection and metrics.
This role ensures the Inspection Administration Program is maintained globally, which includes central oversight over compliance, quality, and efficiency from ongoing inspection readiness.
【職務の内容 / Essential Job Responsibilities】
（雇入れ直後）
• Promote company-wide understanding of QMS and regulatory compliance.
• Evaluate inspection findings for process improvements.
• Conduct and coordinate routine and ad-hoc mock inspections.
• Stay updated on legal, regulatory, and industry standards, and integrate them into education and inspection readiness.
• Drive regulatory compliance and sustainable process improvements.
• Implement and maintain global procedures and core training for inspection readiness.
• Lead or co-lead inspection readiness meetings and ensure timely preparation deliverables.
• Prepare and guide Inspection Management Plans.
• Lead communication for inspection preparation activities.
• Identify gaps and develop strategies to mitigate inspection risks.
• Conduct inspection preparation sessions (mock interviews, training, visits).
• Track and analyze regulatory inspection and audit issues to provide metrics.
• Conduct surveys and capture lessons learned from global inspections for continuous improvement.
• Coordinate responses to regulatory findings and track CAPAs to completion.
• Facilitate the Inspection Administration & Management Network.
• Lead cross-functional process improvement activities.
• Participate in industry forums for inspection readiness benchmarking.
• Manage multiple projects and processes efficiently.
• Demonstrate sound judgment in handling confidential business and compliance information.
• Develop and implement strategies to embed a culture of compliance and accountability.
（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.
【応募要件 / Qualifications】
＜必須 / Required＞
• Bachelor’s degree or equivalent with 5 years of industry experience and 3 years of QA experience.
• Must demonstrate effective communication, writing and interpersonal skills and the ability to interface across multiple departments and external stakeholders.
• Detailed knowledge of GXP regulations, other quality principles and applies current interpretations/trends to Quality documentation and record control.
【応募書類 / Application Documents】
和文履歴書・和文職務経歴書・英文レジュメ
Both Japanese and English Resumes are needed
【選考プロセス / Selection details】
書類選考 → 1次面接 → 2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。
CV screening → First interview → 2nd Interview → Final interview
*Please be advised that there might be a change in the process.
【勤務地 / Location】
（雇入れ直後）
東京都中央区 アステラス製薬 日本橋事業所 本社
Nihonbashi, Tokyo
（変更の範囲）
会社の定める事業場および自宅
【勤務開始日 / Start Date】
応相談
Will be decided according to the candidate's flexibility
【契約期間 / Contract Duration】
期間の定めなし
Not limited to specified period
【試用期間 / Probation Period】
試用期間原則なし
No probation period in principle
【給与 / Salary】
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
①Base salary: will be decided by the candidate's experience, skill and capability.
②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【昇給 / Salary Raise】
有り
【賞与 / Bonus】
有り
【諸手当 / Allowance】
裁量労働手当、住宅手当、通勤手当 等
Discretionary work allowance, Housing allowance, Commutation allowance, etc.
【勤務時間 / Working Hours】
8:45～17:45（月～木）、8:45～16:00（金）、企画業務型 裁量労働制
裁量労働制の場合、所定労働時間を働いたものとみなす
8:45～17:45（Mon～Thu）、8:45～16:00（Fri）
Discretionary Work System
【休日 / Holidays】
完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始
Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays
【休暇 / Vacation Leave】
年次有給休暇、育児休業制度、介護休業制度 等
Annual paid leave, childcare leave system, nursing care leave system, etc.
【福利厚生 / Welfare】
雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System
【アステラス製薬 採用サイト/ Career web site】
https://re-jp.astellas.com/jp/recruit/newgraduates/
For more information about Astellas, please visit our career web site.
"We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law."