Senior Director, Clinical Quality Assurance & Compliance

IQVIA Argentina; Durham (NC); On-site; USD 89,000 - 247,000; Full time

Job summary

IQVIA is seeking a strategic QA leader to oversee global quality programs in clinical research and GxP areas. You will guide risk-based decisions, drive continuous improvement, and ensure regulatory compliance across sponsors and operations.

The role emphasizes patient safety, audit readiness, and collaboration with cross-functional teams to uphold quality governance. The ideal candidate has extensive CQA/GCP experience, strong leadership, and the ability to mentor QA staff while shaping quality

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Healthcare Administration, Biology or related field.
• Minimum of 10 years of Quality Assurance experience in pharma, biotech, CRO, or clinical research.
• Extensive experience interpreting, applying, and overseeing GCP standards in a clinical setting.
• Strong knowledge of R&D processes, clinical trials, and global regulations.
• Experience with GxP quality assurance and CAPA management is advantageous.
• Proven ability to lead complex quality initiatives and influence stakeholders.

Responsibilities

• Serve as the primary QA liaison for customers, sponsors, and internal teams.
• Provide QA oversight of issues, deviations, CAPAs, risk assessments, and compliance initiatives.
• Lead or participate in audit readiness activities and regulatory inspection responses.
• Develop, review, and maintain SOPs; participate in global quality governance initiatives.
• Mentor QA personnel and promote a culture of quality and continuous improvement.
• Analyze audit trends and drive process improvements to reduce risk.

Skills

Quality leadership

GCP/GxP

Regulatory compliance

Audits & CAPA

Risk assessment

SOPs & documentation

QA governance

Mentoring

Cross-functional

Quality metrics

Education

Bachelor's degree (life sciences)

Tools

Quality Management Systems

Microsoft Office

Job description

IQVIA is seeking a strategic QA leader to oversee global quality programs in clinical research and GxP areas. You will guide risk-based decisions, drive continuous improvement, and ensure regulatory compliance across sponsors and operations.

The role emphasizes patient safety, audit readiness, and collaboration with cross-functional teams to uphold quality governance. The ideal candidate has extensive CQA/GCP experience, strong leadership, and the ability to mentor QA staff while shaping quality