R&D Supplier Quality Manager (GxP/AI)

Location: United States - Remote; up to 10% domestic and international travel may be required.

Salary: $104,287.35–$141,094.65 annual base salary

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across areas including heart disease, obesity, rare diseases, inflammatory conditions, and cancer.

What you will do

• Manage risk-based qualification, assessment, audit, governance, and lifecycle oversight of R&D suppliers.
• Oversee suppliers providing, hosting, developing, validating, maintaining, or supporting GxP computerized systems for preclinical and clinical activities.
• Plan, lead, and document supplier audits covering regulatory compliance, validation, data integrity, security, and corrective and preventive actions.
• Review supplier contracts and quality agreements, including requirements for validation, electronic records and signatures, audit trails, subcontractors, data retention, and incident notification.
• Monitor supplier performance, KPIs, deviations, incidents, CAPAs, service changes, and emerging risks; escalate material quality or data integrity concerns.
• Maintain supplier records in quality systems such as Veeva and TrackWise and support inspection readiness and regulatory responses.

Requirements

• Doctorate degree, or a relevant master's degree with 2 years of experience, bachelor's degree with 4 years, associate's degree with 8 years, or high school diploma/GED with 10 years in science, engineering, or a related field.
• Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers.
• Experience with supplier quality risk assessments, audits, computerized system validation, lifecycle practices, electronic records, electronic signatures, audit trails, and data integrity.
• Experience assessing GxP technology suppliers, including software, SaaS, cloud, hosting, infrastructure, implementation, validation, and managed services.
• Experience overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and supplier monitoring.
• Strong communication, problem-solving, collaboration, prioritization, and continuous improvement skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Time-off plans, work-life balance support, and career development opportunities.