Astellas Pharma Inc.

【募集の背景 / Purpose & Scope】

The Joint Venture (JV) Cellafa Bioscience Inc. is established to integrate Astellas cell therapy expertise with Yaskawa Electric’s roboticstechnology to build a seamless cell therapy ecosystem, eliminating key development challenges and generating valuable assets.

セラファ・バイオサイエンス株式会社

The Quality Assurance Manager supports the Head of Quality Assurance by managing and executing day-to-day QA operations for automated, robotics-based cell therapy manufacturing. This role is responsible for the effectiveimplementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuringcompliance with GMP, GCTP, and global regulatory requirements while enabling efficient clinical manufacturing and batch release.

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

The QA Manager is accountable for operational quality assurance activities and acts as a key link between quality strategy and execution.

• Develop, implement, maintain, and continuously improve the Quality Management System (QMS) in alignment with quality strategy and regulatory expectations.

• Develop and manage QA-controlled documentation including SOPs, policies, forms, and records, ensuring timely creation, review, approval, and periodic review.

• Ensure effective document control, training management, and record retention within digital quality systems.

• Lead the operational management of deviations, non-conformances, OOS/OOT, and complaints, including root cause analysis and CAPA development.

• Manage change control processes for manufacturing processes, automation systems, equipment, and digital platforms.

• Ensure timely closure and effectiveness checks of CAPAs.

• Perform or coordinate batch record review for clinical trial material (CTM) manufactured using automated and robotic processes.

• Verify compliance with approved procedures, specifications, and in-process controls prior to batch disposition.

• Support the Head of QA in batch release decisions by providing accurate and complete quality assessments.

• Support validation activities (CSV, equipment qualification, process validation) for automated workflows, robotics systems, and digital quality platforms.

• Review validation protocols, reports, and risk assessments to ensure compliance with GMP and data integrity requirements.

• Ensure appropriate QA oversight of changes to automation logic, software, and data flows.

• Support regulatory inspections (FDA, EMA, PMDA, etc.) and customer audits as a QA representative.

• Prepare and manage responses to inspection findings and audit observations.

• Execute supplier qualifications, quality agreements, and ongoing supplier performance monitoring.

• Review and approve quality documentation from vendors, CMOs, and technology partners related to manufacturing, automation, and digital systems.

• Work closely with Cell Manufacturing, Digital Process Innovation, Engineering, and Technology Development teams to embed quality into daily operations.

• Support technology transfer activities by ensuring quality requirements are appropriately implemented and documented.

• Escalate quality risks, trends, and compliance concerns to the Head of QA in a timely manner.

（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】

・ご入社から安川電機との合弁会社（セラファ・バイオサイエンス株式会社）への出向となります。

• This roll frequently requires long periods of sitting.

• This role will be mainly working at manufacturing facility in Japan.

【応募要件 / Qualifications】

＜必須 / Required＞

• Fluent communication skills in Japanese and business communication skills in English.

• Bachelor’s degree or higher in life sciences, engineering, pharmacy, or a related field.

• At least 5 years of experience in Quality Assurance in Biologics, Cell & Gene Therapy, or CDMO environments.

• Hands-on experience with deviation, change control, CAPA, and batch record review.

• Familiarity with GMP, GCTP, FDA, EMA, PMDA regulations and inspection practices.

• Experience supporting validation activities and digital quality systems (digital QMS, CSV).

• Strong operational QA execution and problem-solving skills

• High attention to detail and data integrity mindset

• Ability to work effectively in a fast-paced, start-up or JV environment

• Strong communication and cross-functional collaboration skills

• Risk-based thinking and continuous improvement orientation

＜歓迎 / Preferred＞

• Strong background in digital QMS, automation validation, and AI-driven quality controls.

• Experience with robotics automation, digital manufacturing, and AI-driven quality control.

• Prior engagement with regulatory agencies on advanced manufacturing technologies.

• Certification in Quality Management Systems (e.g., Six Sigma, ISO 9001, ASQ)

• Certification in Auditing

【応募書類 / Application Documents】

和文履歴書（必須）・和文職務経歴書（必須）・英文レジュメ（任意）

Resumes

【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.

出向後の諸条件（給与・福利厚生等、勤務時間・休日・服務規程）はアステラス製薬の規定を維持します。

【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。

（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】

8:30～17:30（月～木）、8:30～15:45（金）、専門業務型 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。

8:30～17:30（Mon～Thu）、8:30～15:45（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."