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QAG(Quality Agreement) & Supplier management Specialist / Manager

Hikari, Japan

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2021.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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QAG(Quality Agreement) & Supplier management Specialist / Manager

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Job ID R0026483 Date posted 12/28/2020 Location Hikari, Japan

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Job Description

OBJECTIVES/PURPOSE

  • Take ownership in the associated function as a Specialist
  • Drive collaboration in the function to proactively solve problems and continuously improve processes
  • Promote open culture to activate the teamwork

ACCOUNTABILITIES

  • Prepare Quality Agreement for MH(Marketing Holder) / vender in a timely manner.
  • Conduct qualification process of new vender.
  • Keep the qualified venders status up to date.
  • Execute the required functional Quality Tasks to support KPI progress through performance dialogues
  • Encourage team members and themselves to get them motivated and committed
  • Develop and help talents be prepared for next functional lead position with multiple skills
  • Proactively involved 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 GXP, ICH, other related guidelines.
  • Primary knowledge in API, solid dosage forms, parenteral technology, biologics or combination products.
  • Primary 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, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems 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 (Manufacturing, Engineering, Supply Chain, etc.)
  • Interacts with global Quality functions.
  • 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:

  • High school diploma or higher diploma. Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline is prefered.
  • Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
  • Leadership and technical capabilities
  • Business level of English skill is preferred (both verbal and written)

Locations

Hikari, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0026483
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