Manager or Staff, Quality Systems & Compliance, Osaka Site / 大阪工場 品質システム・コンプライアンス担当（課長代理/一般社員）

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Job Description

This job requires native level Japanese proficiency in writing, reading and speaking.

OBJECTIVES/PURPOSE

• Lead and manage the associated function as a Lead Specialist on QS&C
• Drive collaboration across the group/department to proactively solve problems and continuously improve processes
• Develop talents and promote open culture to activate the teamwork

ACCOUNTABILITIES

• Lead and manage QS&C activities assigned from the below and specified in GMP Job Description
  • Responsible for construction and maintenance of document structure of the Site.
  • Responsible for owning, explaining and training of Process for “Good Documentation Practice”
  • Responsible for preparing of annual GMP training plan.
  • Develop, Improve and explain Learning management system.
  • Supervise training coordinators of each department.
  • Introduce innovative training methodologies at the site
  • Business Process Owner for Complaint Handling related SOPs
  • Manage inspection readiness, handling and follow up
  • Lead preparation of PQRs and review of PQRs
  • Manage preparation of regulation documents in a timely manner
  • Responsible for review of assessment and action plan in change control system.
  • Manage and handle change control for timely completion.
  • Explain and train change control system as business process owner.
  • Responsible for review of Validation master plan, protocol and report.
  • Explain and train Validation as business process owner.
  • Manage and promote Data integrity.
  • Manage and prepare Quality Agreement for MH / vender in a timely manner.
  • Manage qualification process of new vender.
  • Manage qualified venders to keep the status up to date.
• Lead and involve team members with priorities, action plans, expected roles, and schedules to get them motivated and committed
• Develop and help talents be prepared for next functional lead position with multiple skills
• Assists/Involved/Lead in the identification and implementation of continuous improvement opportunities (AGILE)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Primary knowledge of the local and international regulatory regulations including GMP, ICH, other related guidelines.
• Primary knowledge in parenteral technology, cell therapy or combination products.
• Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
• Excellent verbal and written communication skills.
• Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
• Experience/expertise with TrackWise Deviation/CAPA, and SAP preferred.

Leadership

• Primary leadership skills and demonstrated success in managing a team.
• Primary interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team lead, share information and deliver results with a team.
• Lead and involve members for bottom-up suggestions through open dialogues

Decision-making and Autonomy

• Primarily be able to deal with ambiguity, and make decisions under stressful conditions with manager’s support.
• Sense of urgency.

Interaction

• Interacts with team members and relevant functions (Quality Control, Manufacturing, Engineering, Supply Chain, etc.)
• Interacts with global Quality functions.
• Interacts frequently with functional peers, and the Quality Leadership Team.
• Share the best practices and expertise in / beyond the group

Innovation

• Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
• Drive initiatives of “Quality Culture”, "AGILE 4.0", "Digital" to drive continuous improvements.

Complexity

• Improve and conduct functional processes within/across the functions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor's degree or higher (in Chemistry, Pharmacy, Engineering, Biology or related discipline is preferred.)
• Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
• Leadership, people management and technical capabilities
• Business level of English skill is preferred (both verbal and written)
• Manufacturing knowledge for the product territory which this job covered. 

ADDITIONAL INFORMATION

This job description is not designed to be a complete list of all duties and responsibilities required of this job

【募集部門の紹介】

品質システムズ＆コンプライアンスグループは、患者様へ届ける医薬品の製造管理及び試験検査を監督し、その品質が確かなものであることを保証するシステム（仕組み）を構築・推進するとともに、国内外の規制当局による査察への対応等、コンプライアンスの維持管理を担っています。

大阪工場で生産する無菌注射剤は、日本国内にとどまらずグローバルに出荷される医薬品のため、関連するグローバルプロジェクト（バリデーション、データインテグリティ、無菌関連など）にも積極的に関与し、プロジェクトをリードしています。

タケダを代表する製剤の製造、品質を強固なものとする取り組みを、一緒に加速していただける方を求めています。

【職務内容】

無菌注射剤の品質保証（GMP）に関わる業務全般

具体的には、

• 品質イベントの管理（逸脱、CAPA、苦情）
• 品質システムの継続的改善に向けた取り組みの推進（リスクレジスター）
• バリデーションプログラムの管理
• 自己点検、製品品質照査、文書管理、教育訓練等の品質保証業務
• 原材料サプライヤー管理
• 国内外の当局査察や顧客による監査への対応

上記業務のいずれかにてリーダーとしての経験を積んでいただきます。

【応募要件】

《学歴》

大学卒業以上

※化学、薬学、工学、生物学、または関連分野の学士号を有していれば望ましい。

《実務経験/スキル：必須》

・医薬品の品質保証、品質管理、製造に関するGMP業務経験および知識

・国内外の査察対応、当局製造販売承認に関わる業務の経験

・PIC/sや三極など当局規制に関する知識

・リーダーシップ力、コミュニケーション力（グループ内だけでなく、クロスファンクショナルに業務対応できるスキル）

《実務経験/スキル：歓迎》

無菌製剤に関する品質保証の業務経験および知識

《語学》

ビジネスレベルの英語力

※会話・文章ともに業務上遂行できるレベルが望ましい。

《保有資格》

薬剤師免許保有者は歓迎します

【求める人物像】

・Global Qualityとの連携の中でBest Practiceをプロアクティブに追求する意欲をもち、新しいアプローチを提案できる方

・科学的な考察により理論構築できる方

Takeda Compensation and Benefits Summary:

• Allowances: Commutation, Housing, Overtime Work etc.

• Salary Increase: Annually, Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

• Flexible Work Styles: Flextime, Telework

• Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the company’s discretion.

• It is possible the department and workplace may change at the company’s discretion.

Locations

Osaka (Juso), Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time