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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 operations
• Demonstrated experience in GMP/GLP, analytical testing, data integrity, and regulatory inspections
• Strong interpersonal, project management, and problem-solving skills
• Ability to operate in a global matrix environment and manage competing priorities

Employee Signature

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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 , Production Sites (Osaka/ Yamaguchi , (Narita , Research Site (Kanagawa
• 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.

Locations:
JPN - Kanagawa - Fujisawa

Worker Type:
Employee

Worker Sub-Type:
Regular

Time Type:
Full time