• 配属地は、ご本人のご希望を踏まえて、下記3拠点いずれかへの配属となります。

茨城県つくば市東光台 / 静岡県焼津市 / 東京都日本橋

【募集の背景 / Purpose & Scope】

This position is responsible for facilitating and implementing the quality assurance strategy to ensure the timely establishment of new product supply and secondary sourcing of compliant, high-quality products. The position provides oversight for Good Manufacturing and Distribution Practices (GMDP) quality assurance in the execution of commercial readiness activities, which include site selection, technology transfer, site inspection readiness, and the transition of quality assurance oversight to Product QA.

As the Commercial Readiness Quality Assurance Lead, this position represents GMDP quality assurance across all applicable regions and leads the global GMDP quality assurance team for assigned products during the commercial readiness phase, ensuring robust and timely quality oversight. With minimal management guidance, the position involves leading relevant quality assurance activities, including the enhancement of the quality management system and the resolution of critical issues through effective risk management.

【職務の内容 / Essential Job Responsibilities】
(雇入れ直後)

• Leads overall GMDP QA oversight for assigned projects during the commercial readiness phase, ensuring compliance with applicable regulations and Astellas procedures. Leads and represents GMDP QA activities for these projects to provide robust and timely quality support until the successful product launch and the transition of responsibilities to Product QA. Key activities include, but are not limited to, commercial site selection and qualification, quality agreement establishment, technology transfer, process validation, mock inspections, regulatory inspection support, nonconformance management, change control, and QA release of PPQ and post-PPQ batches.
• In addition to responsibilities within their own region, serves as the global GMDP QA representative on assigned project teams, providing direction on quality and compliance, communicating compliance issues to management, and overseeing the completion of quality-related action items.
• Foster strong and trusting relationships while promoting collaboration among relevant stakeholders to ensure the successful product launch of the assigned product.
• Responsible for the timely review and approval of GMDP-relevant documents created by the Technology & Manufacturing (T&M) division or GMDP sites, whether internal or external, that are necessary for the quality oversight of assigned products during the commercial readiness phase.
• With minimal management guidance, leads the resolution of quality issues for the assigned project by providing timely and effective quality oversight and collaborating with stakeholders.
• With minimal management guidance, leads risk mitigation and improvement initiatives for quality management systems. Provides GMDP and operational improvement guidance to the Technology & Manufacturing (T&M) division and other key stakeholders for processes governed by GMDP regulatory compliance requirements.
• May have supervisory responsibilities for colleagues within the same team and may serve as a mentor for junior or new team members.

(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>

• BA / BS in a science or engineering related field, with a minimum of 5 years of pharmaceutical industry experience in either CMC or, GMDP, including minimum of 5 years' experience as QA.
• Qualified GMDP Auditor in Astellas or equivalent
• Conversational-level English proficiency

<歓迎 / Preferred>

• Qualified GMDP Lead Auditor in Astellas or equivalent.

【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 → 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 → Final interview

• Please be advised that there might be a change in the process.

【勤務地 / Location】

(雇入れ直後)

茨城県つくば市東光台 アステラス製薬 つくばバイオ研究センター

Tsukuba, Ibaraki

※JRひたち野うしく駅とつくばエクスプレス(TX) 研究学園駅より通勤バスがございます。

静岡県焼津市 アステラス製薬 焼津技術センター

Yaizu, Shizuoka

※焼津駅より通勤バスがございます。

(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-

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."