Sr. Manager, Quality Assurance (Clinical QA)

Location: Chicago, Illinois

Salary: $120,000–$170,000 in Illinois; $140,000–$200,000 in New York City or San Francisco. Compensation may vary for California, Colorado, and New York locations.

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights to support treatment decisions.

What you will do

• Implement, maintain, and continuously improve the clinical Quality Management System across CRO operations, internal systems, and sponsored medical device trials.
• Manage the clinical QA audit program, including internal, client, vendor, investigator site, and Trial Master File audits.
• Qualify and audit clinical vendors and partners while maintaining the approved vendor list.
• Manage document control, CAPA, non-conformance, root cause analysis, and corrective action workflows.
• Track quality trends and metrics, prepare executive reporting, and support regulatory GCP inspections and client audits.
• Consult with cross-functional project teams, represent QA in client interactions, and mentor junior quality staff.

Requirements

• University or college degree in a scientific or technical discipline; life science preferred.
• 6–8+ years of relevant clinical research experience in a research site, biotech, pharmaceutical, or CRO environment.
• Direct experience with drug or medical device clinical trials or clinical data.
• Strong working knowledge of ICH Guidelines, GCP, and international clinical development regulations.
• Excellent communication, organizational, prioritization, and attention-to-detail skills.
• Proficiency with Google Workspace, Microsoft Word, Excel, and electronic QMS or clinical trial platforms.

Nice to have

• 2+ years in people management, project leadership, or a supervisory quality role.
• 6+ years of GCP QA auditing experience.
• Experience working for both a sponsor company and a CRO.
• Early-phase Phase I or Phase II clinical trial experience.

Culture & Benefits

• Full-time employment with a comprehensive benefits package that may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.
• Cross-functional collaboration with clinical, quality, pharmaceutical, CRO, and medical device stakeholders.
• Emphasis on compliance, continuous improvement, education, and root cause analysis.
• Equal opportunity employment environment.