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 requires business level Japanese in speaking, writing, and reading.
About Takeda
"Better Health for People, Brighter Future for the World" is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We're looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company's founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
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.

Locations
Hikari, Japan
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time