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Job Description

The Future Begins Here

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.

This role is in the Takeda Japan Innovation Center (TJIC), as part of the global network of Innovation Capability Centers (ICCs). Our ICCs focus on delivering digital solutions across Takeda and building our internal digital capabilities to ensure we are future-ready.

TJIC collaborates with the global ICCs to supports our Japan based business units and functions with cutting-edge technologies such as AI and big data. As a TJIC member, you will work closely with Japan-based business units and functions while regularly collaborating with colleagues in global ICCs to exchange knowledge and drive innovation.

Being part of TJIC offers a unique opportunity to leverage the latest data, digital and technology practices to solve complex challenges and deliver impactful solutions. You will be empowered to deepen your expertise, enhance your skills and contribute to a mission that makes a meaningful difference in people’s lives worldwide.

At Takeda’s ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.

About the role:

Risk & Compliance Specialist is responsible for overseeing computer systems validation programs across the organization within a regulated cGMP environment. This individual collaborates with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implements risk-based validation strategies, and oversees validation and testing activities using modern tools and methodologies. This role supports Takeda's mission by delivering high-quality, compliant solutions while guiding and developing validation team members to achieve departmental goals.

How you will contribute:

Develop, initiate, and oversee risk-based validation strategies and procedures to ensure compliance with regulatory standards and industry best practices for IT systems and processes.  Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues.  Establish, monitor, and report Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) for validation effectiveness and compliance.  Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions.  Provide leadership in advancing validation frameworks and documentation processes, aligning with business goals and compliance requirements.  Guide and mentor validation team members to develop their expertise and ensure the successful delivery of projects in adherence to Takeda’s compliance standards.Continuously improve validation processes by adopting innovative tools and methodologies to enhance efficiency and effectiveness while maintaining regulatory compliance.Coordinate with cross-functional teams to ensure a seamless approach to validation and compliance initiatives enterprise-wide.

Skills and qualifications:

Must have experience working in agile environment and use of modern quality tools ( e.g. ( JIRA, Confluence, Qtest, etc)Working knowledge of manufacturing IT systems like LIMS,MES, TrackWise,etc.Experience working with virtual teams on a global basisIn depth knowledge of GxP regulations( such as from FDA, EMA, etc) related to Manufacturing  IT systemsAbility to lead teams in the correct interpretation of regulationsGood oral and written communications skills, business acumen with problem solving and analytical skills

Key Responsibilities:

Develop testing protocols such as Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Execute validation tests and compile comprehensive phase reports.Perform risk analysis and mitigation planning for IT systems, laboratory systems, and manufacturing systems.Evaluate and address validation risks associated with system changes, updates, or implementations.Collaborate with external system providers during implementation, ensuring alignment with validation requirements and quality standards.Act as a subject matter expert during validation-related phases of system upgrades or deployments.Maintain detailed and up-to-date validation documentation in compliance with regulatory standards and industry best practices.Investigate deviations, discrepancies, or non-conformances encountered during validation activities and ensure corrective actions are appropriately implemented.Partner with cross-functional teams to establish validation requirements and ensure project goals align with business and regulatory needs.Provide expertise and guidance on validation processes to project teams and stakeholders.Provide training and mentorship to team members and stakeholders regarding validation processes, protocols, and best practices.Serve as a go-to expert for validation-related challenges and initiatives.Stay informed of industry developments, evolving regulations, and emerging technologies related to validation processes and systems.Continuously integrate improvements and ensure alignment with regulatory guidelines.

Qualifications:

8-10  years of experience in a similar roleBachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).Proven experience infrastructure qualification and computer system validation.In-depth knowledge of relevant regulations, guidelines, and industry standards related to CSV, data integrity, and computerized systems (e.g., GAMP 5, 21 CFR Part 11).Familiarity with cloud qualification practices (nice to have).Strong analytical and problem-solving skills.Excellent communication and teamwork abilities.Attention to detail and a commitment to quality.Professional/business level in both English and Japanese will be key to success in the role.

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.

LocationsTokyo, Japan

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time