Senior Clinical Quality Lead - GCP Compliance & Risk

IQVIA; Plano (TX); On-site; USD 63,000 - 216,000; Full time

Job summary

IQVIA is seeking an experienced quality and compliance professional to lead risk-based oversight within designated units. You will partner with global and regional teams to define and adopt the global Quality Plan, ensuring adherence to ICH/GCP, SOPs, and regulatory requirements in clinical operations.

In this role you will support staff, coordinate CAPAs, inspections, and audits, and drive corrective/preventive actions. Travel within the region may be required.

Qualifications

• 9+ years total experience in Clinical Operations or related field.
• Clinical Operations background with GCP/compliance experience.
• Strong site oversight and risk management experience.
• Oncology experience preferred; knowledge of ICH and SOPs.
• Fluent in English; able to travel within the region.

Responsibilities

• Conduct country and site-level compliance oversight using a risk-based approach.
• Identify compliance risks and manage CAPAs.
• Support inspections and audits as the local GCP expert.
• Drive inspection readiness and country-level compliance.
• Adopt and implement the global Quality Management Plan within the scope of the assignment.
• Cooperate with stakeholders to maintain focus on quality in project delivery.
• Provide advice and support on GCP compliance to teams.
• Prepare periodic reports on quality, risk assessments and enhancements.

Skills

Quality management

Risk management

GCP/compliance

Project coordination

Stakeholder collaboration

Communication skills

Travel readiness

English fluency

Education

Bachelor's Degree or equivalent

Tools

Microsoft Office

Job description

IQVIA is seeking an experienced quality and compliance professional to lead risk-based oversight within designated units. You will partner with global and regional teams to define and adopt the global Quality Plan, ensuring adherence to ICH/GCP, SOPs, and regulatory requirements in clinical operations.

In this role you will support staff, coordinate CAPAs, inspections, and audits, and drive corrective/preventive actions. Travel within the region may be required.