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 Takeda’s Privacy Notice (https://jobs.takeda.com/privacynotice) and Terms of Use (https://www.takeda.com/terms-and-conditions/) . 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:_** + 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