Head of Quality (Chengdu, China)

We are seeking an experienced <strong>Head of Quality</strong> to lead our company&#8217;s pharmaceutical quality management function. This role is responsible for establishing, improving, and maintaining a robust <strong>GMP-compliant Quality Management System (QMS)</strong> to ensure product quality, regulatory compliance, and operational excellence across the organization.<br>&#160;<h2><strong>Key Responsibilities</strong></h2><ul><li><p>Lead the development, implementation, and continuous improvement of the company&#8217;s quality management system.</p></li><li><p>Ensure compliance with <strong>GMP and cGMP</strong> standards and regulatory requirements.</p></li><li><p>Oversee all quality-related activities across QA, QC, and Validation functions.</p></li><li><p>Establish and maintain quality management procedures, production control procedures, and standard operating procedures (SOPs).</p></li><li><p>Approve all quality-related changes and manage deviations, complaints, and adverse event investigations.</p></li><li><p>Oversee qualification and validation activities, including review and approval of protocols and reports.</p></li><li><p>Evaluate and approve materials and manage supplier quality performance.</p></li><li><p>Establish and maintain a robust <strong>quality training system</strong>, ensuring all relevant personnel receive appropriate initial and ongoing training.</p></li></ul><p>Collaborate cross-functionally to support continuous improvement and inspection readiness.<br><br><strong>Qualifications</strong></p><p><strong>Education:</strong></p><ul><li><p>Bachelor&#8217;s degree or higher in <strong>Pharmacy, Biomedical Science, or related field</strong></p></li><li><p><strong>Experience:</strong></p></li><li><p><strong>10+ years</strong> of experience in pharmaceutical production and quality management, including at least <strong>5 years in commercial-scale operations</strong></p></li><li><p>Proven experience leading <strong>GMP certification projects</strong> (FDA or EU certification preferred)</p></li></ul><p><strong>Skills &amp; Competencies:</strong></p><ul><li><p>Deep understanding of pharmaceutical regulations and quality systems</p></li><li><p>Excellent leadership, communication, and cross-functional collaboration skills</p></li><li><p>Strong analytical and decision-making abilities</p></li><li><p>Proficient in Microsoft Office (Word, Excel, PowerPoint)</p></li><li>Fluent in <strong>English</strong>&#160;and Mandarin (spoken and written)</li><li><strong>5+ years</strong> of people management experience</li></ul><p><br><strong>&#8203;&#8203;&#8203;&#8203;&#8203;&#8203;&#8203;Compensation and Benefits:</strong><br>The expected base salary range for this position is $200,000 - $300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate&#8217;s qualifications, experience, and skills.<br>While most offers typically fall within the&#160;low to mid-point of the range, we may extend an offer toward the&#160;higher end&#160;for exceptional candidates whose background and expertise&#160;<strong>exceeds</strong>&#160;the requirements of the role.<br>&#160;<br>SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company&#8217;s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.<br>&#160;<br>We offer an opportunity for you to learn and grow while making significant contributions to the company&#8217;s success.<br>&#160;<br>SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.</p>