EMEA Regional Quality & Inspection Lead

IQVIA; Dublin; On-site; EUR 130,000 - 170,000; Full time

Job summary

IQVIA is seeking a Clinical FSP Director of Quality to lead regulatory compliance across clinical trials within the EMEA region. The role drives proactive inspection readiness, audit support, and sustained CAPA remediation, aligning GCP practices with global standards.

You will oversee high-risk inspections, coordinate cross-functional teams, and act as the executive liaison with regulatory authorities to ensure timely, high-quality responses and continuous improvement.

Qualifications

• Strong knowledge of ICH-GCP and regulatory guidelines.
• Extensive experience in CAPA, inspections, and audits.
• Proven leadership in global/regional clinical operations.
• Excellent communication with senior stakeholders.

Responsibilities

• Lead inspection readiness and audit support at regional/global levels.
• Guide clinical teams on inspection expectations and responses.
• Coordinate audit/inspection responses and remediation.
• Drive proactive inspection readiness culture across EMEA.
• Serve as senior escalation point during regulatory inspections and audits.
• Oversee CAPA management, risk assessment, and issue closure.
• Collaborate with GCC, RDQA, and country teams to align strategies.

Skills

GCP knowledge

Regulatory compliance

Stakeholder management

Leadership

Education

Bachelor's degree + 12+ years in clinical research

Tools

Microsoft Office

Clinical management applications

Job description

IQVIA is seeking a Clinical FSP Director of Quality to lead regulatory compliance across clinical trials within the EMEA region. The role drives proactive inspection readiness, audit support, and sustained CAPA remediation, aligning GCP practices with global standards.

You will oversee high-risk inspections, coordinate cross-functional teams, and act as the executive liaison with regulatory authorities to ensure timely, high-quality responses and continuous improvement.