Clinical Program Quality, Associate Director, R&D, China

<p>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 <a href="https://jobs.takeda.com/privacynotice" target="_blank">Privacy Notice</a> and <a href="https://www.takeda.com/terms-and-conditions/" target="_blank">Terms of Use</a>.  I further attest that all information I submit in my employment application is true to the best of my knowledge.</p><p></p><p style="text-align:inherit"></p><h2><b>Job Description</b></h2><p style="text-align:inherit"></p><p><b><span>roles&amp; responsibility</span></b> <span><span><span><b>:</b></span></span></span></p><ul><li>Provides quality assurance oversight of the global and local clinical research programs in Research and Development (R&amp;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.</li><li>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. </li><li>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</li><li>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.</li></ul><p><b><span>R&amp;D Qualifications &amp; Skills</span> </b></p><ul><li>BA/BS degree required; advanced degree preferred.</li><li>Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.</li><li>Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience.</li><li>Recent experience in leading and hosting NMPA/CFDI inspection and other health authority inspection experience with FDA, MHRA etc.</li><li>Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development</li><li>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.</li><li>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</li><li>Strong technical writing skills; able to write quality positions, audit reports, and procedures.</li><li>Excellent communication skills with ability to negotiate and influence without authority in a matrix environment</li><li>Strong judgment, project management, and decision-making skills; able to manage multiple projects and demanding timelines</li><li>Superior attention to detail and ability to analyze complex data</li><li>Able to read Chinese and speak Mandarin fluently</li><li>Able to travel to various meetings, inspections and/or audits, including overnight trips and international travel.</li></ul><p><span><span><span> </span></span></span></p><p style="text-align:inherit"></p><h2><b>Locations</b></h2>Shanghai, China<p style="text-align:inherit"></p><h2><b>Worker Type</b></h2>Employee<p style="text-align:inherit"></p><h2><b>Worker Sub-Type</b></h2>Regular<p style="text-align:inherit"></p><h2><b>Time Type</b></h2>Full time