Global QA Strategy Lead for Clinical Compliance

IQVIA; Durham (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

IQVIA is seeking a senior strategic quality leader to oversee QA programs across clinical research and GxP activities. You will provide risk-based guidance, ensure regulatory compliance, and drive continuous improvement to protect patient safety and data integrity.

In this role, you will coordinate regional and global QA initiatives, mentor QA personnel, and partner with clinical operations, regulatory affairs, and sponsors to ensure audit readiness and effective quality management systems.

Qualifications

• Minimum 10 years of Quality Assurance experience in pharma/biotech/CRO environments.
• Strong knowledge of GCP and GxP regulatory requirements (ICH guidelines).
• Experience auditing, authoring audit reports, evaluating findings, and managing CAPA.
• Proven ability to lead cross-functional quality initiatives and influence stakeholders.

Responsibilities

• Serve as the primary QA liaison for customers, sponsors, and internal teams.
• Provide QA oversight of deviations, CAPAs, risk assessments, and compliance initiatives.
• Lead preparation for regulatory inspections and sponsor/customer audits.
• Develop, review, and maintain SOPs; participate in global quality governance.

Skills

QA Leadership

GCP/GxP

Auditing & CAPA

Risk Management

Regulatory Compliance

Cross-functional Collaboration

Data Integrity

Problem Solving

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology, Chemistry

Tools

MS Office

Quality Management System (QMS)

Job description

IQVIA is seeking a senior strategic quality leader to oversee QA programs across clinical research and GxP activities. You will provide risk-based guidance, ensure regulatory compliance, and drive continuous improvement to protect patient safety and data integrity.

In this role, you will coordinate regional and global QA initiatives, mentor QA personnel, and partner with clinical operations, regulatory affairs, and sponsors to ensure audit readiness and effective quality management systems.