Description

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 <a href="https://jobs.takeda.com/privacynotice" target="_blank">Privacy Notice</a> and <a href="https://www.takeda.com/terms-and-conditions/" target="_blank">Terms of Use</a>. I further attest that all information I submit in my employment application is true to the best of my knowledge.<h2>Job Description</h2>OBJECTIVES/PURPOSE <ul><li>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</li><li>Managing Sterility Assurance Group operations for vaccine manufacturing area</li><li>Managing a scientific strategy development of aceptic environmental monitoring</li><li>Ensure GMP and regulatory compliance including Pharmacopoeias and related guidelines (GMP ministerial guidance in Japan, ICH Q guidelines and so on.)</li><li>Enhance the collaboration among related functions in the site and organization</li><li>Achievement of defined plan with KPIs in order to drive the VBU and Hikari plant to reach operational and compliance excellence</li></ul>ACCOUNTABILITIES <ul><li>Provide the vision of responsible group and achieve related KPIs</li><li>Ensure talent development based on appropriate quality conversations and communications</li><li>Manage and create the current and mid term plan of resources for responsible group</li><li>Oversight environment monitoring activities and ensure the environmental condition in manufacturing area meeting current GMP requirements</li><li>Clarify the concepts and requirements of sterility assurance in vaccine operations and ensure sterility assurance of vaccine products </li><li>Promote the collaboration work with the other function in Vaccine Quality, VBU, Hikari site and GQ organization</li><li>Maintain inspection / audit readiness with appropriate GMP compliance</li></ul>DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise<ul><li>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.)</li><li>Knowledge in sterile product, aceptic process, sterilization process, parenteral technology, biologics and combination products.</li><li>Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations.</li><li>Excellent verbal and written communication skills in Japanese</li><li>Business level verbal and written communication skills in English</li><li>Adaptive communication and presentation skills to effectively reach different levels, including senior management.</li><li>Skilled in Microsoft Office applications (Excel, Powerpoint, Word)</li><li>Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Information Management systems preferred.</li></ul>Leadership<ul><li>Strong leadership skills and demonstrated success in managing a team.</li><li>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.</li><li>Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Plant.</li><li>Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.</li></ul>Decision-making and Autonomy<ul><li>Must be able to deal with ambiguity, and make decisions under stressful conditions.</li><li>Great sense of urgency.</li><li>Agility to act</li></ul>Interaction<ul><li>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.)</li><li>Interacts with Global Quality functions and Regulatory Affairs, as well as local and global regulators.</li><li>Interacts frequently with subordinates, functional peers, and the Senior Leadership Team.</li></ul>Innovation<ul><li>Strong knowledge of Quality Risk Management principles.</li><li>Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.</li><li>Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business.</li><li>Lead and engage employees by initiatives of “Qualtiy Culture” to drive continuous improvements.</li></ul>Complexity<ul><li>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.</li></ul>EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: <ul><li>Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.</li><li>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.</li><li>In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.</li><li>Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law)</li><li>Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.)</li><li>Business level of English skill is necessary (both verbal and written)</li></ul>Preferred<ul><li>License for pharmacist</li><li>Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety.</li><li>Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.</li></ul>ADDITIONAL INFORMATION<ul><li>Some travels will be required.</li><li>This job description is not designed to be a complete list of all duties and responsibilities required of the position.</li></ul>Takeda Compensation and Benefits Summary:<ul><li>Allowances: Commutation, Housing, Overtime Work etc.</li><li>Salary Increase: Annually, Bonus Payment: Twice a year</li><li>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</li><li>Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)</li><li>Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.</li><li>Flexible Work Styles: Flextime, Telework</li><li>Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.</li></ul>Important Notice concerning working conditions:<ul><li>It is possible the job scope may change at the company’s discretion.</li><li>It is possible the department and workplace may change at the company’s discretion.</li></ul><h2>Locations</h2>Hikari, Japan<h2>Worker Type</h2>Employee<h2>Worker Sub-Type</h2>Regular<h2>Time Type</h2>Full time

Group Manager, Vaccine Sterility Assurance Group

Description

Takeda

Pipeline