Senior Quality Assurance Manager

⬇️⬇️⬇️⬇️Senior Quality Manager Location: China (hybrid)The Company:A rapidly growing CDMO specializing in the development and GMP manufacturing of Biologics. The site partners with global pharmaceutical and biotech companies to deliver high-quality clinical and commercial products in full compliance with regulatory requirements.Position Overview:The Quality Manager will lead all Quality Assurance activities on-site, ensuring the quality system, manufacturing operations, and product releases meet the highest GMP and regulatory standards. This role will provide both strategic and operational leadership to the QA team, ensuring robust quality governance, compliance readiness, and continuous improvement of the Quality Management System.Key Responsibilities:Lead and manage the Quality System team, including daily operations, deviation/CAPA management, change control, and risk management.Establish and maintain a compliant Quality Management System covering manufacturing, testing, and distribution processes.Oversee product complaint, return, and recall investigations, ensuring timely resolution.Develop, maintain, and implement quality agreements across the product lifecycle, from development to commercial manufacturing.Review and approve quality system documentation, standard operating procedures, and regulatory submissions.Organize and participate in GMP quality system reviews and the annual quality review of commercial products.Conduct GMP training for cross-functional teams to maintain compliance culture.Lead internal and external audits, including regulatory inspections, client audits, supplier audits, and due diligence inspections.Ensure maintenance of production licenses, regulatory reporting, and compliance with corporate information security requirements.Drive continuous improvement initiatives across the QMS to support operational excellence and site growth.Candidate Profile:BS degree or higher in a scientific discipline; advanced degrees preferred.8+ years in a regulated pharmaceutical, biotech or CDMO environment5 years in a GMP Quality Assurance roleQA experience and regulatory submission experience in China is a plus.Proven leadership experience managing QA teams and fostering accountability.Strong knowledge of GMP, ICH guidelines, and domestic/international regulatory requirements.Ability to manage multiple priorities, with strong organizational and problem-solving skills.Mandarin and English speaking.I look forward to receiving your application! 🎄