Quality Compliance Specialist

Job description

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: About the role: This Quality Compliance Specialist is responsible for managing external regulatory inspections and responding to regulatory observations while leading GMP compliance projects. How you will contribute: - Manage external regulatory inspections, lead local inspection readiness efforts, oversee inspection and support rooms, escorting regulatory agents, and serve as a subject matter expect during inspections. - Draft responses to regulatory inspection reports, collaborating with multiple departments under short deadlines to ensure accurate and appropriate responses. - Editing skills are important. - Promote on-time completion of corrective action commitments made to regulatory authorities. - Coordinate efforts associated with GMP re-certification and product licensing. - Lead projects to mitigate top GxP compli...