Group Manager, Vaccine Sterility Assurance Group
Job Description
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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) 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
**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) 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