Manager, Quality Project Management, Hikari Site / 光製薬品質部 品質プロジェクトマネジメント 課長代理

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Job Description

Please note this job requiresbusiness level Japanese in speaking, writing, and reading.

About Takeda

OBJECTIVES/PURPOSE

• Facilitate and management of the Digital Core System delivery for Hikari Quality, supporting rapid DX. This includes optimizing and streamlining processes using digital technologies.
• Collaborate with cross-functional stakeholders to simplify and standardize Quality Processes, supporting project management for Hikari Quality, and aiming for overall quality enhancement across the organization.
• Lead the acceleration of Digital Innovation through partnerships with Tokyo HC, Osaka (Juso) and Narita.
• Engages stakeholders to work towards common goals, driving Digital transformation across the organization.
• Responsible for research and analysis on Digital market trends to identify technological advancements opportunities, and provide recommendations based on the market analysis.
• Promote Quality Culture initiatives through collaboration and partnerships with stakeholders, facilitating organizational transformation.
• Responsible for timely and effective communication and escalation process to the Head of Quality Project Management, ensuring project progress and outcomes are effectively reported.

ACCOUNTABILITIES

• Manage defined strategic transformation project.
• Lead and facilitate Hikari Quality DX and Digital Lab project collaboration with Tokyo HQ, Osaka (Juso) and Narita.
• Research and analyze digital market trends to identify technological advancements opportunities.
• Promote the collaboration with the other function in Quality and GMSGQ, DD&T organization.
• Drive and coordinate Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization, including appropriate tools and training.
• Ensures adherence to EHS program
• Manage Quality Culture initiatives (Hikari Culture and DE&I)

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines.
• Knowledge in Digital, automation, LIMS, AGILE or Lab excellence are preferable.
• 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 in Japanese
• Business level verbal or written communication skills in English
• Adaptive communication and presentation skills to effectively reach different levels, including senior management.
• Skilled in Microsoft Office applications (Excel, Powerpoint, Word, Power BI)
• Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.

Leadership

• Strong leadership skills and demonstrated success in managing a team.
• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders (DDT, Tokyo HC and GQ Japan region other site), cooperate as a leadership member, share information and deliver results with a team.
• Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Quality team.

Interaction

• Interacts with the Site Quality Head, Site Quality Control Head, Site QSI Head and other relationship functions (DD&T, Region Quality Team)
• Interacts frequently with subordinates, functional peers, DD&T (Tokyo HC (XD Lab team)) and other GMS/GQ counter partners.

Innovation

• Strong knowledge of Project Management and Change Management principles.
• Should be current in knowledge of state-of-the DX and technology related to GMP area.
• Identify and implement strategic opportunities to drive digital transformation, Quality system and Business Operation in site-business.

Complexity

• Key stakeholders include but not limited to: Quality Control, Quality Assurance, Manufacturing, Supply Chain, Distribution, DD&T, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Bachelor’s degree in IT and digital, system engineering, data analysis, chemistry, Pharmacy, Engineering, Biology or related discipline is preferable.
• An experience in the following areas in the pharmaceutical industry: Quality assurance, Quality Control, Quality system, Manufacturing, Excellence; understanding of the requirements for manufacturing, computer systems and project management.
• Basic knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
• Good leadership skills (i.e. Communication, Project Management, Decision Making, Problem Solving, Team building and etc.)
• Well-knowledge related to Manufacturing, Finance, EHS, DD&T and HR (incl. Labor law)
• Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
• Business level of English skill is necessary (both verbal and written)

ADDITIONAL INFORMATION

• This job description is not designed to be a complete list of all duties and responsibilities required of the position.
• Location: Hikari (Tokyo HQ or other sites are negotiable.)
• As stakeholders are located across multiple sites in Hikari and Tokyo HQ, there is no specific location requirement; however, approximately monthly travel to Hikari Site is required for communication with team members and supervisors.

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.

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