Senior QA Auditor: Clinical Compliance & Quality Lead

IQVIA; Glendale (AZ); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking a Quality Assurance professional to plan and conduct independent clinical (GCP) audits across IQVIA contracts, ensuring compliance with regulations, guidelines and SOPs. You will prepare reports for supervision, operations staff, management and customers, and provide interpretations of regulations and policies.

Responsibilities include leading audit activities, evaluating findings, preparing CAPA and EC plans, and supporting continuous process improvements while maintaining the

Qualifications

• Bachelor's degree preferred.
• Travel 30-50%.
• 5 years experience in pharmaceutical, technical, or related area, including 3 years in Quality.
• Experience in Assurance Audits and GCP.
• Experience conducting clinical trial Investigator site audits.
• Experience in clinical study report/data management/biostatistics audits preferred.
• Knowledge of word processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical R&D processes and regulatory environments.
• Knowledge of quality assurance processes.

Responsibilities

• Plan, schedule, conduct, report and close audit activities in IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
• Evaluate audit findings and prepare/distribute reports to operations staff, management and customers.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans.
• Review, approve investigations, RCA, CAPA and EC plans and track till closure for quality events arising from audits and QA activities.
• Evaluate policies and procedures for compliance and provide recommendations for continuous process improvements.
• Maintain the electronic quality management system (eQMS) and support the audit lifecycle.
• Lead/collaborate/support QA initiatives/projects for quality and process improvements.
• Assist in training of new Quality Assurance staff.
• May be required to manage Quality Issues.
• May present educational programs and guidance to operational staff on compliance procedures.
• May perform pre-inspection visits and host audits/inspections; assist in regulatory facility inspections.

Education

Bachelor's Degree Pref

Job description

IQVIA is seeking a Quality Assurance professional to plan and conduct independent clinical (GCP) audits across IQVIA contracts, ensuring compliance with regulations, guidelines and SOPs. You will prepare reports for supervision, operations staff, management and customers, and provide interpretations of regulations and policies.

Responsibilities include leading audit activities, evaluating findings, preparing CAPA and EC plans, and supporting continuous process improvements while maintaining the