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Job Description

OBJECTIVES/PURPOSE

Provide global GxP Quality oversight of laboratory activities (method development, validation, release, stability) across modalities.Ensure implementation and execution of data integrity and quality system standards in internal and external laboratories.Partner with cross-functional teams to support analytical lifecycle management and regulatory submission readiness.Lead key quality initiatives and investigations related to laboratory operations.

ACCOUNTABILITIES

Provide quality oversight for internal GxP and non-GxP laboratories performing analytical activities across the R&D pipeline.Review and approve GMP/GLP documentation including method validation protocols/reports, deviations, CAPAs, and audit responses.Ensure appropriate implementation of ALCOA+ principles and data integrity controls in laboratory systems and workflows.Lead or support laboratory-related investigations and inspections, ensuring timely root cause analysis and sustainable CAPA.Collaborate cross-functionally with Pharmaceutical Sciences, Regulatory Affairs, Manufacturing, and other Quality functions.Participate in the preparation and review of analytical sections for regulatory filings (IND/CTA/NDA/BLA).Contribute to the development and improvement of global procedures, standards, and quality frameworks for laboratory oversight.Monitor quality performance trends and proactively escalate compliance risks or improvement opportunities.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Strong understanding of GxP regulations, analytical methods, and laboratory operations across modalities (small molecules, biologics required; cell/gene therapy, plasma, or vaccines a plus).Demonstrated application of data integrity principles and computerized system controls in laboratory environments.Experience with internal and external laboratories, technical agreements, and audit preparation.Proficiency in quality risk management, deviation handling, and CAPA effectiveness.

Leadership

Supports strategic goals of the R&D GMP Quality organization.Coaches junior team members or cross-functional partners on quality principles.Effectively communicates quality expectations and analytical requirements.Influences decision-making in cross-functional settings and supports change management efforts.

Decision-making and Autonomy

Exercises judgment in resolving laboratory-related quality events and compliance issues.Makes independent decisions within the scope of analytical QA responsibilities.Provides recommendations for quality risk mitigation and system improvements.

Interaction

Collaborates with Analytical Development, QC, Manufacturing, Regulatory, and QA teams.Interfaces with external laboratories and CMOs as required.Participates in regulatory inspections, audits, and governance meetings.

Innovation

Contributes to process improvements and implementation of digital solutions.Promotes knowledge sharing and continuous improvement culture within the team.Identifies new tools or practices to enhance laboratory compliance and efficiency.

Complexity

Supports laboratory oversight across a range of modalities and global sites.Navigates matrixed organizational structures and diverse cultural and regulatory landscapes.Balances scientific, compliance, and business needs in decision-making.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

Bachelor's degree in Life Sciences, Chemistry, Biochemistry, or related field. Preffered advance degree (MS/PhD)7+ years of relevant industry experience in quality oversight of laboratory operationsDemonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspectionsStrong interpersonal, project management, and problem-solving skillsAbility to operate in a global matrix environment and manage competing priorities

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Manager Signature:

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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.

LocationsJPN - Kanagawa - Fujisawa

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time