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Job Description: Title : Sr. Manager, R&D Quality Compliance and Systems: Location Lexington, MA / Zurich, Switzerland: About the Role: As a Sr. Manager, R&D Quality Compliance and Systems, you will provide cross functional expertise and input to the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement. You will provide key input to the establishment of the framework for quality oversight of the R&D Quality Management System. Serve as a Quality Partner across R&D Quality and contribute to the design, implementation and advancement of the R&D Quality Management System operations.
How will you contribute:
Responsible for autonomously executing activities associated with the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation. Partners with RDQ to develop plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities.
Responsible for the implementation of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs. Responsible for authoring, editing, and circulating for approval the associated family of documents.
Ensure the execution of the RDQ Regulatory Intelligence program, rev