Job Description

General Information

Job Advert Title: Specialist, Pharma QA Operational Governance & Strategy

Location: Nihonbashi, Tokyo

Division: Quality Assurance

Employment Class: Permanent

Description

【募集の背景 / Purpose & Scope】

This position collaborates with the commercial manufacturing site QA in Pharma QA / Bio Pharma QA to focus on document standardization activities and support/manage various activities for operational excellence.

Responsible for development, implementation and management of standardized quality processes and governing the site operations so that the Astellas in-house plants within Pharma operate with a single, consistent and sophisticated GMP standard.

Supports efficient operational management aligned to the circumstances of each site within Pharma QA, while coordinating with relevant stakeholders where broader alignment or quality input is required.

【職務の内容 / Essential Job Responsibilities】

（雇入れ直後）

Responsibilities

１　Collaborate with the manufacturing site's QA team to promote the standardization of procedural documents.

２　Lead or coordinate initiatives to ensure that plant-wide standard operating procedures (SOPs) are consistently applied and maintained.

３　Oversee the registration and maintenance of plant-wide SOPs in the Vault Quality system, ensuring compliance with regulatory and internal standards.

４　Conduct periodic reviews and updates of plant-wide SOPs to ensure they remain current and effective.

５　Implement activities to raise awareness of standardization projects among relevant stakeholders, ensuring that team members and related functions are informed and engaged.

６　Identify opportunities for improvement within manufacturing site QA processes and provide actionable proposals and support for enhancements.

７　Participate in cross-functional teams as needed, collaborating with other departments to achieve common goals and improve overall quality assurance practices.

８　Support manufacturing site and team for authority and/or internal self-inspection, and related CAPA activities.

９　Manage with team Head to ensure various activities for Phama QA operational excellence.

Accountabilities:

１　Ensure that procedural documents are standardized and compliant with industry regulations and internal requirements.

２　Maintain accurate records of SOP registrations and updates in the Vault Quality system.

３　Foster a culture of continuous improvement within the QA team and across relevant manufacturing site interfaces.

４　Act as a liaison between the QA team and other departments to facilitate effective communication and collaboration.

５　Report on the progress of standardization initiatives and process improvements to management, including relevant risks, issues and proposed actions where appropriate.

（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】

This position is based in Japan, working closely with commercial manufacturing site QA, and will be offered a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.

【応募要件 / Qualifications】

＜必須 / Required＞

１　Science Graduate or equivalent professional qualification and/or proven expertise

２　Experience of working at Quality Assurance Department of GMP pharmaceutical manufacturing site

３　Knowledge of Quality Assurance area, related general systems (Veeva, Trackwise, and LMS)

４　Strategical and logical thinking

５　Knowledge of GMP and other regulations as required with a broad knowledge of quality principles

６　Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the internal Astellas and external stakeholders.

７　Ability to develop and maintain effective relationships with internal and external stakeholders including Global Astellas entities.

８　Makes communications for the department in their area of quality expertise.

９　Ability to coordinate activities across multiple global stakeholders or sites, and to provide practical quality input based on GMP and operational understanding. Business proficient in English.

＜歓迎 / Preferred＞

Science, industrial chemistry, biological chemistry or pharmaceutical degree preferred.

【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）

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."