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OBJECTIVES/PURPOSE
- Provide leadership of sterility assurance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel develop-ment
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Managing Sterility Assurance Group operations for vaccine manufacturing area
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Managing a scientific strategy development of aceptic environmental monitoring
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Ensure GMP and regulatory compliance including Pharmacopoeias and related guidelines (GMP ministerial guidance in Japan, ICH Q guidelines and so on.)
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Enhance the collaboration among related functions in the site and organization
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Achievement of defined plan with KPIs in order to drive the VBU and Hikari plant to reach operational and compliance excellence
ACCOUNTABILITIES
- Provide the vision of responsible group and achieve related KPIs
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Ensure talent development based on appropriate quality conversations and communications
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Manage and create the current and mid term plan of resources for responsible group
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Oversight environment monitoring activities and ensure the environmental condition in manufacturing area meeting current GMP requirements
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Clarify the concepts and requirements of sterility assurance in vaccine operations and ensure sterility assurance of vaccine products
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Promote the collaboration work with the other function in Vaccine Quality, VBU, Hikari site and GQ organization
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Maintain inspection / audit readiness with appropriate GMP compliance
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
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Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines. (GMP ministerial guidance in Japan, ICH Q guidelines and M guidelines and so on.)
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Knowledge in sterile product, aceptic process, sterilization process, parenteral technology, biologics and combination products.
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Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.
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Excellent verbal and written communication skills in Japanese
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Business level verbal and written communication skills in English
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Adaptive communication and presentation skills to effectively reach different levels, including senior management.
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Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
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Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Information Management systems preferred.
Leadership
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Strong leadership skills and demonstrated success in managing a team.
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Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, egender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
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Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant.
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Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
Decision-making and Autonomy
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Must be able to deal with ambiguity, and make decisions under stressful conditions.
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Great sense of urgency.
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Agility to act
Interaction
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Interacts with the Vaccine Quality Japan Head and all relevant site functions (e.g. VBU-Japan Manufaturing, GQ, EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.)
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Interacts with Global Quality functions and Regulatory Affairs, as well as local and global regulators.
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Interacts frequently with subordinates, functional peers, and the Senior Leadership Team.
Innovation
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Strong knowledge of Quality Risk Management principles.
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Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
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Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business.
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Lead and engage employees by initiatives of “Qualtiy Culture” to drive continuous improvements.
Complexity
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Key stakeholders include but not limited to: VBU-Japan Manufacturing, Vaccine testing, Quality Control, Quality Assurance, Hikari Site Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
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Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
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At least 5 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality Control; understanding of the requirements for manufactur-ing, plant utilities, computer systems and project management.
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In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
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Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)
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Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)
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Business level of English skill is necessary (both verbal and written)
Preferred
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License for pharmacist
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Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety.
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Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.
ADDITIONAL INFORMATION
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Some travels will be required.
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This job description is not designed to be a complete list of all duties and responsibilities required of the position.
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:
Hikari, Japan
Employee
Regular
Full time
