Director of Quality Assurance

Job Summary

As the Director of Quality Assurance, this full-time position will manage and oversee the clinical Quality Management System (QMS) while ensuring compliance with ICH-GCP and international regulations, with options for hybrid or remote work based in Chicago.

Key Responsibilities

• Champion the strategic vision for clinical compliance and QMS across internal systems and clinical operations
• Empower cross-functional teams by acting as a mentor and subject matter expert on clinical validation architectures
• Design team architecture and efficiencies, collaborating with stakeholders to enhance QA operations and structural efficiencies

Required Qualifications

• University/college degree in a scientific or technical discipline, preferably life science
• Minimum of 10+ years of relevant clinical research experience in research sites, biotech, pharma, or CRO
• Extensive knowledge of ICH Guidelines and GCP, including international regulatory requirements
• Demonstrated ability to manage multiple competing priorities effectively
• Proficient in Google platform, Microsoft Word, Excel, and modern electronic QMS/clinical trial platforms