Astellas Pharma Inc.

【募集の背景 / Purpose & Scope】

The Joint Venture (JV) is established to integrate Astellas cell therapy expertise with Yaskawa Electric’s robotics technology to build a seamless cell therapy ecosystem, eliminating key development challenges and generating valuable assets. The Head of Quality Assurance (QA) will lead the development and execution of the company’s Quality Management System (QMS), ensuring compliance with GMP, GCTP, FDA, EMA, PMDA, and other global regulatory requirements. This role will be responsible for integrating quality oversight with robotics-driven automation processes, ensuring robust data integrity, risk management, and regulatory readiness for clinical manufacturing.

https://www.astellas.com/jp/news/29761

The selected candidate will first join Astellas as an employee and undergo several months of training focused on Astellas’ Quality Management System (QMS), standards, and procedures. This preparatory period is designed to build foundational knowledge and ensure alignment with Astellas’ quality culture and expectations as well as to initiate contribution to designing and establishment of QMS at the JV. Upon successful completion of the training, the individual will be seconded to the Joint Venture to assume their role as Head of Quality Assurance.

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

•Undergo structured training on Astellas’ Quality Management System (QMS), including global quality policies, procedures, and documentation practices.

•Participate in cross-functional training programs to understand Astellas’ approach to GxP compliance, risk management, and data integrity.

•Shadow experienced QA leaders within Astellas to gain hands-on experience with quality oversight of cell therapy manufacturing processes.

•Engage with relevant Astellas departments (e.g., Regulatory Affairs, Manufacturing, Process Development) to build internal networks and facilitate knowledge transfer to the JV.

•Contribute to the development of transition plans, including gap assessments and integration strategies for adapting Astellas’ QMS principles to the JV environment.

•Support the drafting or adaptation of SOPs, quality manuals, and training materials intended for use in the Joint Venture.

•Prepare for a leadership role in the JV by participating in strategic planning discussions related to quality organization design, regulatory inspection readiness, and facility qualification.

（出向時）

The Head of Quality Assurance will report to the CEO of the JV and will be responsible for entire quality assurance of the JV for CTM manufacturing of cell therapy products and release.

•Establish and implement the Quality Assurance strategy from scratch aligned with the company’s mission, regulatory requirements, and industry best practices.

•Develop a Quality Management System (QMS) tailored for automated, robotics-based cell therapy manufacturing including but not limited to define in-process control (IPC) and batch review strategies suitable for automated workflows, establish robust change control, CAPA, and deviation handling processes.

•Ensure validation of automated workflows, digital platforms, and AI-driven quality control processes.

•Ensure compliance with GMP, GCTP, FDA, EMA, PMDA, and other applicable regulatory requirements including support regulatory submissions (IND, BLA, MA, etc.) and interactions with regulatory agencies.

•Provide strategic leadership on quality culture, fostering a right-first-time and continuous improvement mindset.

•Collaborate with Digital Process Innovation, Cell Manufacturing, and Technology Development teams to integrate quality into process development and one-click technology transfer.

•Oversee the development and maintenance of QA policies, SOPs, batch release processes, and deviation management systems.

•Ensure data integrity and compliance with digital quality systems for automated manufacturing environments.

•Lead audit readiness for regulatory inspections and customer audits and serve as the primary QA liaison with regulatory agencies for inspections, filings, and compliance matters.

•Ensure effective supplier and material qualification programs.

•Provide QA oversight for cell therapy manufacturing using robotics automation and closed-system processing.

•Partner with parent companies, technology vendors, and automation partners to ensure compliance with quality and regulatory expectations.

（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】

・ご入社数か月～半年後を目安に、安川電機との合弁会社への出向を想定しております。

•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.

•Advanced degree (MS/PhD) in Life Sciences, Biotechnology, Engineering, or related field.

•10+ years of QA experience in Biologics, Cell & Gene Therapy, or CDMO environments.

•Proven experience in leading quality functions in an automated/robotics-driven manufacturing setting.

•Deep understanding of GMP, GCTP, FDA, EMA, PMDA, and ICH guidelines for cell and gene therapies.

•Experience in regulatory submissions (IND, BLA, NDA, MA, etc.) and global inspections.

•Ability to thrive in a fast-paced startup/CDMO environment with a hands-on approach.

•Excellent leadership, communication, and cross-functional collaboration skills.

＜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)

【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.

【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】

当人の経歴・技術・技能等を考慮して決定

Will be decided by the candidate's experience, skill and capability.

【昇給 / Salary Raise】

有り

【賞与 / Bonus】

有り

【諸手当 / Allowance】

住宅手当、通勤手当　等

Housing allowance, Commutation allowance, etc.

【勤務時間 / Working Hours】

管理監督者　8:30～17:30（月～木）、8:30～15:45（金）

Managers and Supervisors　8:30～17:30（Mon～Thu）、8:30～15:45（Fri）

【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."