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Job Description:

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
Managing Sterility Assurance Group operations for vaccine manufacturing area
Managing a scientific strategy development of aceptic environmental monitoring
Ensure GMP and regulatory compliance including Pharmacopoeias and related guidelines (GMP ministerial guidance in Japan, ICH Q guidelines and so on.)
Enhance the collaboration among related functions in the site and organization
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
Ensure talent development based on appropriate quality conversations and communications
Manage and create the current and mid term plan of resources for responsible group
Oversight environment monitoring activities and ensure the environmental condition in manufacturing area meeting current GMP requirements
Clarify the concepts and requirements of sterility assurance in vaccine operations and ensure sterility assurance of vaccine products
Promote the collaboration work with the other function in Vaccine Quality, VBU, Hikari site and GQ organization
Maintain inspection / audit readiness with appropriate GMP compliance


DIMENSIONS AND ASPECTS :

Technical/Functional (Line) Expertise:
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.)
Knowledge in sterile product, aceptic process, sterilization process, parenteral technology, biologics and 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 in Japanese
Business level verbal and 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)
Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Information Management 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, egender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.

Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant.

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:
Must be able to deal with ambiguity, and make decisions under stressful conditions.
Great sense of urgency.
Agility to act


Interaction:
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.)
Interacts with Global Quality functions and Regulatory Affairs, as well as local and global regulators.
Interacts frequently with subordinates, functional peers, and the Senior Leadership Team.


Innovation:
Strong knowledge of Quality Risk Management principles.

Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.

Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business.
Lead and engage employees by initiatives of "Qualtiy Culture" to drive continuous improvements.


Complexity:

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 :
Bachelor's degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.

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.

In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
Well-knowledge related to Manufacturing, Finance, EHS 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)

Preferred

License for pharmacist

Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety.

Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.


ADDITIONAL INFORMATION:
Some travels will be required.

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 , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
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
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