Clinical Quality & Compliance Lead (FSP)

Regulatory Jobs; Durham (NC); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA seeks an experienced QA/Quality Lead to join our global quality management efforts for clinical trials. You will partner with delivery units, sponsors, and business lines to drive GCP compliance and risk mitigation, guiding staff and stakeholders in quality improvements.

With a minimum of eight years in clinical trial processes and knowledge of SOPs and regulatory standards (ICH/GCP), you will lead QA activities, audits, and corrective actions while collaborating across regions to ensure

Qualifications

• Minimum 8 years in clinical trial design, planning, startup, conduct, analysis, and reporting.
• Bachelor's Degree or equivalent.
• Knowledge of ICH, GCP, SOPs, and regulatory requirements.
• Knowledge of drug development and CRO/pharma industry operations.
• Strong organizational, interpersonal, and communication skills.
• Willingness to travel within the region/country and lead teams.

Responsibilities

• Adopt and implement the global Quality Management Plan within scope.
• Support quality management in project delivery with stakeholders.
• Develop and monitor a Delivery Unit Quality Plan and risk program.
• Provide guidance on GCP compliance and SOPs to teams.
• Prepare periodic quality reports for line management.

Skills

Clinical trial design

Regulatory knowledge

Communication skills

Leadership

Problem solving

Microsoft Office

IQVIA SOPs

CRO/pharma ops

Travel ability

Team motivation

Education

Bachelor's Degree

Job description

IQVIA seeks an experienced QA/Quality Lead to join our global quality management efforts for clinical trials. You will partner with delivery units, sponsors, and business lines to drive GCP compliance and risk mitigation, guiding staff and stakeholders in quality improvements.

With a minimum of eight years in clinical trial processes and knowledge of SOPs and regulatory standards (ICH/GCP), you will lead QA activities, audits, and corrective actions while collaborating across regions to ensure