Senior Clinical Quality Associate

Job Summary

A company is looking for a Senior Clinical Quality Associate.

Key Responsibilities

• Lead Clinical Quality Assurance activities for clinical studies and ensure compliance with regulatory requirements
• Develop and maintain Quality Management Plans and conduct audits of clinical vendors and sites
• Provide training on SOPs, GCP, and regulatory updates to clinical and cross-functional teams

Required Qualifications

• Bachelor's degree in Biology, Chemistry, or a relevant scientific discipline preferred
• 3-5 years of full-time GCP Quality Assurance experience
• Strong knowledge of FDA regulations and GCP standards
• Experience with cell therapy clinical studies is preferred
• Proficient in MS Office products