Compliance and Quality Specialist

The Local Compliance Specialist ensures an integrated and comprehensive quality and compliance approach for clinical trials in close collaboration with the sponsor's local and global quality functions, and ensures clinical trials are performed in compliance with local laws and regulations, industry standards and sponsor's processes and procedures. Key responsibilities may include execution of various QC checks, Quarterly Quality Reviews (QQR), audit and inspection support, CAPA support, local SOP management, new hire onboarding / training, SOP / GCP consultation, country regulatory intelligence, local vendor management, and support of Local Operating Company (LOC) Management Reviews.

Key Responsibilities :

Quality and Compliance Oversight :

• Monitor compliance risk and ensure mitigation / remediation actions are defined.
• Monitor progress and confirm effectiveness of remediation plans, e.g. by performing QC checks or special investigations.
• Participate in Quarterly Quality Reviews with local GCO management addressing compliance issues and risk signals.
• Collaborate with local and central business partners to facilitate inspections and office audits as needed.
• Collaborate with local and central business partners in timely CAPA setting and implementation. Provide Quality Event Management (QEM) CAPA Champion support and / or regional lead responsibilities such as training, account management, etc.
• Develop and manage local procedural documents.
• Execute Trial Master File (TMF) QC checks and On-Site Compliance Monitoring Visits (OSCMVs).
• Support operational projects for GCO Compliance,

Local Onboarding and Consultation :

Local regulatory intelligence :

Collaborate with Business Quality to support LOC Management Review and local supplier assessments, as appropriate.

Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.

Full utilization by timely and accurate time reporting.

Requirements :

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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