Quality Control Lead-上海（Contract）

1. Inspection Readiness & Regulatory Support • Support NMPA, CFDI, and other regulatory inspections, including: • Partner with Biogen CCL to develop CFDI inspection plan and inspection readiness activities • Contribute to GCP inspections and ensure smooth organization of the front office and back office • Provide responses and address questions and observations during inspection • Follow-up implementation of CAPAs and ensure timely completion 2. Co-MV Planning and Execution • Develop and maintain China Co-MV plans aligned with global quality strategies. • Define Co-MV scope, frequency, and prioritization based on protocol risk, site performance, and study phase. • Track and trend Co-MV findings to identify systemic risks and recurring issues. 3. Clinical Trial Quality Oversight • Lead risk-based QC activities for China clinical trials. • Perform QC reviews of critical trial documents, including but not limited to: • Investigator Site Files (ISF) • Trial Master File (TMF) • Informed Consent Forms (ICF) • Monitoring reports and follow-up letters • Safety reporting documentation • Ensure data integrity and patient safety are consistently protected throughout trial execution. • Development, implementation, and verification of CAPAs 4. Drive continuous improvement initiatives to enhance trial execution quality in China.