Group Manager, Vaccine Sterility Assurance Group

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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.

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