GCP Auditor - Global R&D Audit (Biotech)

Location: United States - Remote; up to 40% international travel may be required.

Annual salary: USD 104,725.10–141,686.90.

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Plan, conduct, and report routine and direct GCP compliance audits internationally.
• Serve as lead auditor for complex GCP audits.
• Identify and communicate compliance risks to R&D Quality management.
• Host or support regulatory authority inspections of clinical sites and company facilities.
• Lead or contribute to R&D Quality process improvement initiatives.
• Author and contribute to cross-functional controlled documents.

Requirements

• Must be based in the United States; the role is remote and may involve up to 40% international travel.
• Doctorate degree; or a master’s degree with 2 years, bachelor’s degree with 4 years, associate’s degree with 8 years, or high school diploma/GED with 10 years of experience in a scientific discipline, medical sciences, or pharmacy.
• Extensive experience conducting international GCP audits or working as a regulatory authority inspector.
• Excellent written and verbal communication skills.

Nice to have

• Postgraduate qualification.
• Participation in process improvement initiatives.
• Experience with data mining, data manipulation, and data analytics.

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 and stock-based long-term incentives.
• Paid time off, work-life balance support, and career development opportunities.