Qin Zhu

· Own and manage $323MM spending on medical kitting components (medical devices, OR accessories, commodities, packaging raw materials), delivering 3% year-over-year cost reduction through contract negotiations, and sustained margin improvement · Drive working capital improvements by extending supplier payment terms from Net 30 to Net 60, balancing financial performance with long-term supplier partnership health across 80+ vendors across North America, Asia, and Europe. · Lead end-to-end sourcing strategy and execution from RFP to supplier onboarding, influencing key business decisions to secure competitive pricing, mitigate risk, and ensure supply continuity · Champion supplier performance management through KPI governance, business reviews, and strategic initiatives, driving continuous cost savings and value creation · Act as a key cross-functional partner to marketing, procurement, quality (QRA), and finance, aligning priorities and leading initiatives that improve process efficiency and speed-to-market · Negotiate complex, high-value contracts and lead resolution of supplier disputes, protecting company interests and minimizing operational and financial risk · Coach and inspire junior team members on sourcing strategies, supplier negotiations, and procurement best practices, contributing to overall team capability and performance · Manage and prioritize multiple high-impact initiatives, influencing stakeholders and delivering results in a fast-paced, matrixed environment · Leverage procurement and analytics tools (SAP, PRMS, Kinaxis, Suplari, Apttus, Ariba, Oracle Agile) to enable data-driven decision-making and uncover strategic opportunities

· Led and governed GMP/GDP supplier inspection readiness programs, establishing standardized qualification and audit frameworks aligned with FDA cGMP, GDP, and ISO 13485 requirements · Executed 20–25 annual supplier qualification and surveillance audits, directly supporting inspection readiness and ensuring compliance with global regulatory expectations and inspection lifecycle management · Owned supplier quality oversight processes, including quality agreement governance and regulatory expectation alignment across 140+ global suppliers · Managed and monitored supplier quality performance across key regulatory risk indicators (CAPA, complaints, recalls, audit outcomes), driving proactive remediation and continuous inspection readiness · Partnered with cross-functional stakeholders to enhance digital Quality Systems, supporting CAPA (SmartSolve), audit management, and change control processes to strengthen regulatory compliance and inspection support · Contributed to enterprise One Quality System initiatives, leading process mapping and continuous improvement efforts to standardize NPI and change control workflows across a complex global environment · Demonstrated strong stakeholder engagement and executive communication, influencing suppliers and internal leadership to align on quality expectations and regulatory commitments · Drove operational excellence initiatives, improving audit processes, supplier performance visibility, and system effectiveness across enterprise Quality functions · Planned and delivered enterprise-level Supplier Day training, engaging 150+ participants globally to reinforce regulatory expectations and quality standards

· Responsible for final documentation review for manufacturing batch release and investigation of out of specification non-conformance incidents from drug manufacturing process · Support immediate launch on the day of patent expiry to maximize generic marketing share · Performed QA review and approval of batch records, ensuring accuracy, completeness, and compliance with cGMP requirements prior to product release · Led and supported investigations of deviations, OOS (out-of-specification), and non-conformance events, ensuring robust root cause analysis and timely CAPA implementation · Provided QA oversight to manufacturing operations, ensuring adherence to procedures, regulatory requirements, and data integrity standards · Maintained inspection-ready documentation and records, supporting internal audits and regulatory inspections · Collaborated cross-functionally with Manufacturing, QC, and Technical Services to resolve quality issues and improve process reliability · Supported product launch readiness, including expedited QA review during time-sensitive commercialization (e.g., patent expiry launches)