Quality Control Lead-上海（Contract）

职位描述

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.

任职要求

• Preferable 8 years of experience in clinical research, with:

• Solid background in Clinical Operations, QA, or QC

• Direct experience supporting China regulatory inspections

• Strong understanding of:

• ICH-GCP

• NMPA/CFDI regulations

• China clinical trial operational practices