Manager of Clinical Quality Assurance

Job Summary

To ensure quality oversight in clinical operations, the full-time remote Manager of Clinical Quality Assurance will manage audit plans, evaluate compliance with regulations, and lead quality oversight for clinical study programs and post-marketing activities.

Key responsibilities

• Manage CQA activities, including the development of audit plans and oversight of clinical quality assurance processes
• Conduct audits of clinical investigator sites and generate audit reports summarizing results
• Lead process improvement initiatives and provide regulatory compliance advice to various departments

Required qualifications

• Bachelor's degree in Regulatory Affairs, Health Administration, Pharmaceutical Science, or a related field
• Five years of experience in a pharmaceutical, biotechnology, or healthcare environment
• Experience in managing CQA activities and conducting system/process-related audits
• Familiarity with global clinical regulatory environments and relevant regulations (e.g., 21 CFR Part 11, ICH E6 (R2))
• Experience utilizing Quality Management Systems