Head, Quality Assurance Group, Narita Quality / 成田製薬品質部 製品保証グループ グループマネージャー

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Job Description

Please note this job requiresbusiness level Japanese in speaking, writing, and reading.

About Takeda

OBJECTIVES/PURPOSE

• Provide leadership of Quality Assurance functions. Develops and deploys mid and long-term plan with KPIs and operational excellence, training/education, talent review and personnel development
• Managing aspects of Quality Assurance of drug substances and drug products at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements.
• Ensure that Batch Record Review activities are effective and carried out on schedule.
• Ensure GMP compliant release of product manufactured and released on site as per the Marketing Authorizaton.
• Review and approve site deviation investigations and assess product impact
• Drive GMP on the shopfloor adherence in manufacturing area
• Achievement of defined plan with KPIs in order to drive the Narita plant to reach operational and compliance excellence

ACCOUNTABILITIES

• Manages the Quality Assurance organization making sure the site goals are cascaded into the department.
• Manage Quality Batch Record Review process for products in Narita.
• Support Product Shipping / Release Process and Product Disposition according to Narita site Shipping and Release target dates
• Review and approve plant deviation investigations and product impact assessments
• Guarantee that systems under Quality Assurance are managed according to Quality Systems global and local procedures and metrics
• Manage Quality on the floor activities in order to guarantee GMP Compliance and Continuous Improvement in Manufacturing areas
• Manage the bioburden control program for process intermediates, critical/support systems and cleanrooms and perform investigations in case of deviations or negative trends
• Support manufacturing department during day by day activities and act as primary Quality contact for issues containment and resolution

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines.
• Knowledge in Plasma Derived Therapeutic processes including sterile operations and packaging operations.
• 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 both Japanese and 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 and SAP systems.

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 Narita 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.

Interaction

• Interacts with the Site Head and all site functions (Business Excellence, EHS, HR, Finance, IT, Manufacturing, Engineering and Supply Chain)
• 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”, "AGILE 4.0" "Digital" to drive continuous improvements.

Complexity

• Key stakeholders include but not limited to: Quality System & Compliance, Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovisilance, Regulatory Affairs, and Health Authorities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree or graduated technical college 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 system & compliance, Quality Control; understanding of the requirements for manufacturing, 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.)

Preferred

• License for pharmacist
• Business level of English skill is necessary (both verbal and written)
• MBA
• Experience of overseas assignment.
• Experience in managing team with applicable perspectives
• 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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