Senior QA Auditor

Senior QA Auditor at Lifelancer in Durham, North Carolina, United States (nationwide) (nationwide) of America

About This Position

The Senior QA Auditor role at Lifelancer involves conducting independent audits to ensure compliance with regulations and operating procedures across IQVIA contracts. The position requires the preparation and distribution of audit reports and providing consultation on regulatory matters. This is a full-time, non-remote job based in Durham, North Carolina.

Key Responsibilities

• Plan, schedule, conduct, report, and close audit activities to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs, and project-specific guidelines/instructions.
• Evaluate audit findings and prepare reports for operations staff, management, and customers.
• Provide interpretation and consultation on regulations, guidelines, compliance status, and policies and procedures to project teams and customers.
• Manage Quality Issues by presenting educational programs, providing guidance to operational staff, reviewing and approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) plans, and tracking their closure for quality events arising from audits or inspections.
• Offer quality assurance consultancy activities and projects within budget and established timelines.

Skills & Qualifications

• Demonstrated experience in conducting independent audits to assess compliance with regulations and guidelines.
• Strong knowledge of IQVIA SOPs, project-specific guidelines/instructions, and customer requirements.
• Able to prepare and distribute reports effectively.
• Excellent communication skills for consultation on regulatory matters.
• Experience in managing quality issues, including investigations, RCA, CAPA plans, and effectiveness checks.
• Strong organizational and project management skills.

Why Join Lifelancer

Lifelancer offers a dynamic environment where you can contribute to the success of global health initiatives. As a Senior QA Auditor, you will play a crucial role in ensuring compliance with regulations and guidelines, supporting operations staff, management, and customers.

Applying for This Role

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there. Please ensure all required fields are filled out accurately to increase your chances of being considered.

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.