Group Manager, Vaccine Sterility Assurance Group

By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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:

• Bachelors 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 companys discretion.

• It is possible the department and workplace may change at the companys discretion.

Locations

Worker Type

Worker Sub-Type

Time Type