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
Clinical Associate • Madison, Wisconsin, United States