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, protcol and report.
  • Explain and train Validation as bussiness 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 commited
• 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, egender 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 “Qualtiy Culture”, "AGILE 4.0", "Digital" to drive continuous improvements.

Complexity

• Improve and conduct functional processes within/across the functions

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• High school diploma or higher diploma. Bachelor’s degree 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

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

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