Senior QA Auditor (GCP Audits)

Location: Durham, North Carolina, United States of America; travel required 30–50%

Salary: $75,400–$188,600 annualized base pay

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

• Plan, schedule, conduct, report, and close independent GCP audits across countries involved in hirify.global contracts.
• Assess compliance with regulations, guidelines, customer requirements, SOPs, and project-specific instructions.
• Evaluate audit findings and prepare reports for operations staff, management, and customers.
• Consult project teams, customers, and monitors on regulations, observations, compliance status, and corrective action plans.
• Review and approve investigations, root cause analyses, CAPA, and effectiveness check plans, tracking quality events through closure.
• Support eQMS activities, inspections, training, and quality or process improvement initiatives.

Requirements

• Bachelor’s degree preferred, or an equivalent combination of education, training, and experience.
• At least 5 years of experience in pharmaceutical, technical, or related fields, including 3 years in quality assurance audits.
• GCP experience and experience conducting clinical trial investigator site audits.
• Extensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance procedures.
• Strong problem-solving, risk analysis, negotiation, communication, organization, training, and interpersonal skills.
• Ability to work independently, manage multiple projects, and maintain effective relationships with coworkers, managers, and clients.

Nice to have

• Experience auditing clinical study reports, data management, biostatistics, or other clinical trial activities.
• Knowledge of word-processing, spreadsheet, and database applications.

Culture & Benefits

• Full-time employment with health and welfare benefits.
• Potential incentive plans, bonuses, and other compensation may be offered.
• Work involves collaboration with operational teams, management, customers, and clinical research stakeholders.
• Opportunity to contribute to compliance improvement, employee training, and regulatory inspection readiness.