Clinical Quality Manager

<p><b>Purpose:</b><br />Ensure implementation and oversight of the GCP Quality Management System (QMS) for clinical development activities in China, aligned with global standards and regulatory requirements, while driving digital and AI-related initiatives.</p><p><b>Key Responsibilities</b></p><ul><li><b>Quality Management &amp; Compliance</b><ul><li>Implement GCP QMS strategy locally; maintain Level 1 GCP quality documents.</li><li>Ensure consistency with regulatory expectations through planning, monitoring, and continuous improvement.</li><li>Act as Subject Matter Expert (SME) and point-of-contact for clinical quality requirements, promoting Quality-by-Design principles.</li></ul></li><li><b>Inspection &amp; Audit Readiness</b><ul><li>Ensure inspection readiness and manage regulatory inspections with cross function.</li><li>Serve as primary contact for audit response management as needed</li></ul></li><li><b>Vendor Quality Oversight</b><ul><li>Develop and execute Vendor Quality Plans; monitor vendor compliance.</li><li>Drive remediation strategies for vendor quality issues and ensure timely resolution.</li></ul></li><li><b>Quality Culture &amp; Training</b><ul><li>Promote GCP quality culture across teams and vendors.</li><li>Conduct knowledge-sharing sessions and embed learnings into QMS systems for continuous improvement.</li></ul></li><li><b>Digital &amp; AI Innovation</b><ul><li>Actively contribute to digital and AI initiatives in China, including STRAT projects.</li><li>Support AI-enabled Site Start-Up (SSU), participant recruitment, eSource, Care anywhere initiatives, and data analysis.</li><li>Collaborate with global and local teams to implement AI-driven solutions for quality improvement and operational efficiency.</li></ul></li><li><b>Collaboration</b><ul><li>Engage with internal and external experts to monitor trends and implement best practices.</li></ul></li></ul><p><b>Qualifications</b></p><ul><li>Advanced scientific/technical degree preferred (MS/MD/PhD); business coursework desirable.</li><li><b>Experience:</b><ul><li>Minimum 5 years in Clinical Development Quality roles with increasing responsibility.</li><li>Strong knowledge of GCP principles, clinical development process (Phases I–IV), and regulatory requirements.</li></ul></li><li><b>Skills:</b><ul><li>Project management, strategic planning, and complex decision-making.</li><li>Excellent communication and stakeholder engagement skills (local and global).</li><li><b>Digital &amp; AI Competency:</b><ul><li>Solid understanding of AI concepts and applications in clinical development.</li><li>Ability to lead or significantly contribute to AI-driven initiatives (SSU, recruitment, eSource, etc).</li></ul></li></ul></li></ul><p></p><p></p>&nbsp;&nbsp;<br>Work Location Assignment:&nbsp;On Premise<br><p style="text-align:inherit"></p><p style="text-align:left"><span><span><span><span><span><span><span><span><span>Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</span></span></span></span></span></span></span></span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Quality Assurance and Control<p></p><p></p>