Director, (GCP) Quality Assurance (GCP)

Location: Hybrid in Chicago or remote within the United States

Salary: $160,000–$200,000 per year; the range may vary by location, qualifications, and experience.

Company

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

What you will do

• Lead the strategic oversight and scaling of the clinical Quality Management System across internal systems, CRO operations, and sponsored medical device trials.
• Oversee GCP quality frameworks for clinical trials and ensure risk-based execution of required quality elements.
• Manage internal, investigator site, trial master file, client, vendor, and partner audits.
• Oversee vendor qualification, approved supplier management, document control, CAPA, and non-conformance programs.
• Host and support regulatory GCP inspections and provide executive management with quality trends and metrics.
• Build QA organizational efficiencies, mentor cross-functional teams, and promote continuous improvement through root-cause analysis.

Requirements

• University or college degree in a scientific or technical discipline; life science is preferred.
• At least 10 years of relevant clinical research experience across a research site, biotech, pharmaceutical, or CRO environment.
• Experience with drug and/or device clinical trials and extensive knowledge of ICH Guidelines, GCP, and international regulatory requirements.
• Strong organization, communication, prioritization, attention-to-detail, and stakeholder relationship-building skills.
• Proficiency with Google tools, Microsoft Word and Excel, and modern electronic QMS or clinical trial platforms.

Nice to have

• At least 5 years of leadership experience at a CRO, biotech, or pharmaceutical company.
• At least 10 years of prior GCP QA experience.
• Experience working for both a sponsor company and a CRO.
• Early-phase clinical trial experience.

Culture & Benefits

• Full-time position with medical and other benefits depending on the role.
• Potential incentive compensation and restricted stock units.
• Flexible hybrid or remote work arrangement within the United States.
• Equal opportunity employment environment.