Head of Medical Device & SaMD Quality
Takeda Pharmaceutical Company(2 months ago)
About this role
Senior global quality leader responsible for defining and executing Takeda’s quality strategy for medical devices, combination products, IVDs, and SaMD across development and commercial lifecycles. Oversees the design, implementation, and continuous improvement of operations and global quality systems to ensure regulatory compliance and inspection readiness. Based in Lexington, MA, the role leads a large distributed team and partners with R&D, Regulatory, Engineering, and Commercial stakeholders.
Required Skills
- Quality Systems
- Regulatory Compliance
- SaMD Validation
- Risk Management
- Team Leadership
- Inspection Readiness
- Quality Strategy
- Stakeholder Engagement
- Product Lifecycle
Qualifications
- BS in Engineering or Life Sciences (required)
- MS or PhD (preferred)
About Takeda Pharmaceutical Company
takeda.comTakeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
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