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** **roles& responsibility** **:** + Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU), and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness. + Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice. + Defines and implements a risk-based program audit strategy, ensuring the communication of significant quality and compliance risks to key stakeholders and Management, and ensuring appropriate and timely investigations and mitigations are in place + Leads the inspection readiness programs, the management of the inspection, and the response and follow-up activities. Ensures that inspection risks are well-communicated and mitigated for both sponsor and investigator site inspections. **R&D Qualifications & Skills** + BA/BS degree required; advanced degree preferred. + Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry. + Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience. + Recent experience in leading and hosting NMPA/CFDI inspection and other health authority inspection experience with FDA, MHRA etc. + Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development + Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective action plans that mitigate risks to the company, patient safety and data integrity. + Collaborative team player proficient in stakeholder management, possessing a positive attitude, critical thinking skills, and the ability to swiftly identify creative solutions to complex problems + Strong technical writing skills; able to write quality positions, audit reports, and procedures. + Excellent communication skills with ability to negotiate and influence without authority in a matrix environment + Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines + Superior attention to detail and ability to analyze complex data + Able to read Chinese and speak Mandarin fluently + Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel. **Locations** Shanghai, China **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time