Senior QA Auditor, Genomics Compliance & Quality

IQVIA Argentina; Durham (NC); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA Laboratories in Durham, NC, seeks a Senior QA Auditor in Genomics Laboratory to plan and conduct independent quality audits. You will provide expert compliance guidance, support quality improvements, and ensure regulatory readiness in a fast-paced research environment.

The role involves leading audits, reviewing findings, and coordinating with teams, management, and clients. A Bachelor's degree is preferred with 5 years in pharma or related fields, including 3 years in QA, and strong GXP

Qualifications

• A Bachelor's Degree is preferred.
• 5 years experience in pharmaceutical, technical, or related area, with 3 years in Quality Assurance.
• GXP experience.
• Knowledge of pharmaceutical R&D processes and regulatory environments.
• Familiarity with QA processes and eQMS.

Responsibilities

• Plan, schedule, conduct, and close audit activities to evaluate compliance with regulations, guidelines, customer requirements, and company procedures.
• Review audit findings, prepare reports, and communicate results to teams, management, and clients.
• Provide guidance on regulatory requirements, quality standards, and procedural interpretation.
• Support investigations, RCA, CAPA, and effectiveness checks through to closure.
• Host and support customer audits, mock inspections, and regulatory inspections.
• Maintain and support electronic Quality Management System activities and quality event management.
• Lead or contribute to quality improvement initiatives and compliance programs.
• Assist with onboarding and training of QA personnel

Skills

Problem solving

Risk analysis

Negotiation

Decision making

Communication

Team collaboration

Organizational skills

Education

Bachelor's degree

Tools

Word processing

Spreadsheets

Databases

eQMS

Job description

IQVIA Laboratories in Durham, NC, seeks a Senior QA Auditor in Genomics Laboratory to plan and conduct independent quality audits. You will provide expert compliance guidance, support quality improvements, and ensure regulatory readiness in a fast-paced research environment.

The role involves leading audits, reviewing findings, and coordinating with teams, management, and clients. A Bachelor's degree is preferred with 5 years in pharma or related fields, including 3 years in QA, and strong GXP