Description
Please note this job requiresbusiness level Japanese in speaking, writing, and reading.
"Better Health for People, Brighter Future for the World" is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We're looking for like-minded professionals to join us.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company's founding. Takeda-ismincorporates and with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
• This position has responsibility for Quality Assurance, and support of Quality Control, for external Small Molecule and Oncology Contract Manufacturing Organisations (CMOs), Suppliers, located within the Japan and Asia region, inclusive of Drug product, QC testing, pack-aging and labelling activities.
• The role holder will establish the strategy and plans for the Quality External Operations Japan/APAC team organisation to meet the Global Quality and Small Molecule and Oncology (SM&O) Operating Unit vision and objectives, establish priorities, build a regional patient-centred best in class organisation, develop di-verse talent and elevate organisational performance, and execute on Quality improvement projects, and where appropriate, manage the finances of the team.
• The role holder is responsible for the Quality oversight of a portfolio of Contract Manufactures and associated products. The position requires interaction with numerous functions within the SM&O Operating Unit, and other External Operations regions, with Takeda manufacturing sites, Takeda Local Operating Companies (LOCs), and external partners.
Relevant experience
• Minimum of 12 years of QA/QC experience in the pharmaceutical industry and/or QA/QC laboratory environment.
• 10+ years of increasing management responsibility combined with strong technical operations background.
• Broad understanding of global Health Authorities requirements in the GMP and GDP regulated area; detailed knowledge of Japan GMP, EU/US GMP, ICH, and other relevant regulations.
Education
• Minimum of Bachelor's Degree in Pharmacy, Chemistry, Biology or related discipline.
Technical Skills
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
• Leadership – ability to effectively lead and motivate a team of direct reports, provide a unifying vision, build on strengths, and address areas for improvement.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and higher-level management.
• Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
• Regulatory understanding – broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing and packaging.
• Excellent intercultural communication, negotiation, and practical problem solving skills.
• Cross functional and matrix management. Preferred experience in large, multi-national, matrixed organizations.
Languages
• Fluent in written and spoken English.
Relevant experience
• At least 6 years of direct people management experience is desired.
Technical Skills
• Project Management expertise
• Hybrid work (work at office at least 8 times / month)
• Domestic / International travel as needed (up to approximately 30%)
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) 8:30-17:30, 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
Click to find out Takeda's Diversity, Equity & Inclusion
Better Health, Brighter Future
Locations
Osaka (Juso), JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time-
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