Clinical Audit Lead – GCP & QA

AbbVie; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

AbbVie seeks a quality assurance professional to lead clinical audits ensuring compliance with ICH-GCP, regulations, and AbbVie policies. You will plan and execute audits, communicate findings, and support GCP inspections as part of the global QA program.

The role requires strong project management, effective communication, and a willingness to travel internationally to sites and affiliates. A science/healthcare degree with biopharma experience is preferred, with opportunities to collaborate

Qualifications

• Bachelor's degree in science or healthcare (3-5 years biopharma experience).
• Strong knowledge of ICH-GCP, clinical trial regulations, and industry best practices.
• Effective project management and communication skills with willingness to travel internationally.

Responsibilities

• Lead clinical audits to assess compliance with regulations and AbbVie policies.
• Support GCP inspections and advance the global quality assurance system.
• Schedule, plan, and conduct clinical audits and communicate results within target timeframes.
• Review corrective action plans and track actions to completion.
• Promote continuous education on quality and clinical guidelines.

Skills

ICH-GCP knowledge

Clinical trial regulations

Project management

Communication skills

Travel willingness

Education

Bachelor's degree in science or healthcare

Job description

AbbVie seeks a quality assurance professional to lead clinical audits ensuring compliance with ICH-GCP, regulations, and AbbVie policies. You will plan and execute audits, communicate findings, and support GCP inspections as part of the global QA program.

The role requires strong project management, effective communication, and a willingness to travel internationally to sites and affiliates. A science/healthcare degree with biopharma experience is preferred, with opportunities to collaborate