By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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
Date
Manager Signature
Date
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
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