Global Clinical QA Auditor Lead

IQVIA Argentina; Glendale (AZ); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking an experienced QA Auditor to lead independent GCP audits across a diverse clinical research portfolio. You will collaborate with global teams to ensure compliance and drive continuous quality improvements.

The role requires travel 30-50% and a strong knowledge of regulatory environments, with the ability to interpret policies for project teams and support CAPA activities.

Qualifications

• Experience in the conduct of clinical trial Investigator Site Audits.
• Travel 30-50%.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• GCP experience.
• Extensive knowledge of pharmaceutical R&D processes, regulatory environments, and QA procedures.
• Strong interpersonal, problem solving, risk analysis and negotiation skills.
• Ability to initiate tasks and work independently.
• Knowledge of word-processing, spreadsheet, and database applications.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts to assess compliance.
• Evaluate audit findings and prepare and distribute reports to stakeholders.
• Provide interpretation and consultation to project teams on regulations and policies.
• Formulate CAPA plans with monitors and customers for corrective actions.
• Review investigations, RCA, CAPA and EC plans and track closure for quality events.
• Evaluate policies and procedures for compliance and recommend improvements.
• Maintain the electronic quality management system (eQMS) and support QA initiatives.

Skills

Investigator Site Audits

GCP Experience

Quality Assurance

Regulatory Knowledge

Interpersonal Skills

Project Management

Education

Bachelor's Degree

Job description

IQVIA is seeking an experienced QA Auditor to lead independent GCP audits across a diverse clinical research portfolio. You will collaborate with global teams to ensure compliance and drive continuous quality improvements.

The role requires travel 30-50% and a strong knowledge of regulatory environments, with the ability to interpret policies for project teams and support CAPA activities.