Global Clinical Quality & Compliance Lead

IQVIA Argentina; Maple Grove (MN); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA in the United States seeks an experienced Quality Lead in Clinical Operations to define and implement the global Quality Plan across delivery units and sponsors. You will advise on quality control, risk management, and CAPAs, and support inspections and audits to ensure GCP compliance.

Responsibilities include country and site-level oversight, risk assessments, and developing delivery-unit quality and risk management programs. Travel within region may be required.

Qualifications

• 9+ years total experience.
• Clinical Operations background with GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred.
• Bachelor's Degree or equivalent qualification.
• Knowledge of ICH, GCP, SOPs and regulatory requirements.
• Knowledge of CRO or Pharmaceutical industry operations.
• Fluent in English.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks, conduct site assessments, and manage CAPAs.
• Support inspections and audits as local GCP expert.
• Drive inspection readiness and country-level compliance.
• Develop and monitor a Delivery Unit/Sponsor Quality Management plan and Risk Management Program.
• Provide guidance on GCP compliance to teams; monitor non-compliance and CAPAs.
• Prepare periodic quality reports for lines of business.

Job description

IQVIA in the United States seeks an experienced Quality Lead in Clinical Operations to define and implement the global Quality Plan across delivery units and sponsors. You will advise on quality control, risk management, and CAPAs, and support inspections and audits to ensure GCP compliance.

Responsibilities include country and site-level oversight, risk assessments, and developing delivery-unit quality and risk management programs. Travel within region may be required.