Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)

Location: Must be located near RTP, North Carolina or Silver Spring, Maryland, with reporting to the office at least four days per week. Up to 50% travel is required, including international travel, and independent travel without restriction is required.

Salary: $88,000–$135,000 per year.

Company

hirify.global is a publicly traded biotech and pharmaceutical company developing therapies for rare diseases and technologies to expand the availability of transplantable organs.

What you will do

• Conduct initial, routine, internal, supplier, CMO, and service-provider audits covering GMP/GDP quality systems, manufacturing, packaging, facilities, distribution, analytical processes, technical reports, and design history files.
• Develop risk-based audit schedules and plans, prepare detailed reports, evaluate responses and corrective action plans, and track open compliance issues.
• Prepare vendor risk assessments and risk control plans using supplier quality events, change notifications, and quality history data.
• Manage and oversee the GxP Vendor List, including new material part numbers and vendor requests.
• Support regulatory inspections, product and quality investigations, development projects, product launches, and vendor management training.
• Review quality procedures, policies, vendor change notifications, and initial quality agreements for regulatory consistency.

Requirements

• Bachelor’s degree in a science or engineering-related field.
• At least 5 years of experience auditing or managing suppliers in an FDA-regulated medical device or pharmaceutical industry.
• Strong knowledge of US cGMP pharmaceutical and medical device regulations, including 21 CFR Parts 4, 11, 210, 211, and QMSR, plus familiarity with ISO and ICH standards.
• Valid passport or ability to obtain one, with the ability to travel independently and without restriction.
• Strong attention to detail, organization, prioritization, communication, and computer skills, including Microsoft Office.
• Must be located near RTP, North Carolina or Silver Spring, Maryland and work from the office at least four days per week.

Nice to have

• Master’s or PhD in a science or engineering-related field.
• ASQ Certified Quality Auditor or ISO lead auditor certification.
• RAPS Regulatory Affairs Certification.
• Experience auditing sterile, solid-dose, or biologic manufacturing operations and reviewing medical device development documents and Design History Files.
• Experience with SAP, Trackwise Digital, MasterControl, and interpreting multiple compendia.

Culture & Benefits

• Mission-driven environment focused on unmet medical needs, rare diseases, and organ transplantation technologies.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), and ESPP savings plans.
• Paid time off, paid parental leave, and disability benefits.
• Work includes collaboration with internal departments, vendors, service providers, and government personnel.