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Job Description
This job requires native level Japanese proficiency in writing, reading and speaking.
OBJECTIVES/PURPOSE
Lead and manage the associated function as a Lead Specialist on QS&C
Drive collaboration across the group/department to proactively solve problems and continuously improve processes
Develop talents and promote open culture to activate the teamwork
ACCOUNTABILITIES
Lead and manage QS&C activities assigned from the below and specified in GMP Job Description
Responsible for construction and maintenance of document structure of the Site.
Responsible for owning, explaining and training of Process for “Good Documentation Practice”
Responsible for preparing of annual GMP training plan.
Develop, Improve and explain Learning management system.
Supervise training coordinators of each department.
Introduce innovative training methodologies at the site
Business Process Owner for Complaint Handling related SOPs
Manage inspection readiness, handling and follow up
Lead preparation of PQRs and review of PQRs
Manage preparation of regulation documents in a timely manner
Responsible for review of assessment and action plan in change control system.
Manage and handle change control for timely completion.
Explain and train change control system as business process owner.
Responsible for review of Validation master plan, protocol and report.
Explain and train Validation as business process owner.
Manage and promote Data integrity.
Manage and prepare Quality Agreement for MH / vender in a timely manner.
Manage qualification process of new vender.
Manage qualified venders to keep the status up to date.
Lead and involve team members with priorities, action plans, expected roles, and schedules to get them motivated and committed
Develop and help talents be prepared for next functional lead position with multiple skills
Assists/Involved/Lead in the identification and implementation of continuous improvement opportunities (AGILE)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Primary knowledge of the local and international regulatory regulations including GMP, ICH, other related guidelines.
Primary knowledge in parenteral technology, cell therapy or 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.
Skilled in Microsoft Office applications (Excel, Powerpoint, Word)
Experience/expertise with TrackWise Deviation/CAPA, and SAP preferred.
Leadership
Primary leadership skills and demonstrated success in managing a team.
Primary interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team lead, share information and deliver results with a team.
Lead and involve members for bottom-up suggestions through open dialogues
Decision-making and Autonomy
Primarily be able to deal with ambiguity, and make decisions under stressful conditions with manager’s support.
Sense of urgency.
Interaction
Interacts with team members and relevant functions (Quality Control, Manufacturing, Engineering, Supply Chain, etc.)
Interacts with global Quality functions.
Interacts frequently with functional peers, and the Quality Leadership Team.
Share the best practices and expertise in / beyond the group
Innovation
Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products.
Drive initiatives of “Quality Culture”, "AGILE 4.0", "Digital" to drive continuous improvements.
Complexity
Improve and conduct functional processes within/across the functions
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelor's degree or higher (in Chemistry, Pharmacy, Engineering, Biology or related discipline is preferred.)
Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
Leadership, people management and technical capabilities
Business level of English skill is preferred (both verbal and written)
Manufacturing knowledge for the product territory which this job covered.
ADDITIONAL INFORMATION
This job description is not designed to be a complete list of all duties and responsibilities required of this job
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.
