Auditor, RDQA Clinical Quality Audit

AbbVie

. Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits .

Posted 10/8/2026full-timeRemote • Illinois • United StatesMid-LevelSenior💰 $84,500 - $162,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Audit execution, including planning, reporting, and compliance with GCP regulations. Proficient in Quality Assurance processes and continuous improvement initiatives within the biopharmaceutical industry.

Highest-signal resume keywords

Clinical Audit ExecutionQuality AssuranceGCP RegulationsAnalytical SkillsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical AuditQuality System DevelopmentCorrective Action PlansClinical Research DevelopmentRegulatory ComplianceData AnalysisQuality StandardsContinuous ImprovementGCP InspectionsClinical Trial Regulations

Soft Skills

Interpersonal SkillsCommunication SkillsFlexibilityTeam CollaborationIndependence

Industry Keywords

Biopharmaceutical IndustryICH-GCPEU Clinical Trial DirectiveQuality Assurance Best PracticesClinical Guidelines

About the role

Key responsibilities & impact

Execute the Clinical audit program, including scheduling, planning, reporting, and resolution of Clinical audits
Ensure alignment with RDQA policies and procedures
Contribute to development and implementation of the Clinical QA quality system
Provide advice and support on GCP and quality topics to business partners
Evaluate Clinical processes through audits and QA oversight activities for quality and compliance
Lead and participate in Clinical Audit scheduling, planning, and conduct activities
Conduct investigator clinical site, process, system, and Affiliate audits
Communicate audit results orally and in writing within target timeframes
Review and approve Corrective Action Plans and track actions to completion
Contribute to development and implementation of systems and processes supporting global quality assurance requirements
Support maintenance or development of Quality standards relating to Clinical audit
Contribute to continuous improvement initiatives and projects
Participate in and support GCP inspections as required
Provide support and consultation to RDQA and business partners regarding GCP regulations
Promote continuous education on quality, clinical guidelines, and regulations

Requirements

What you’ll need

Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy), or equivalent experience
3–5 years of experience in the biopharmaceutical industry or with a regulatory authority
3–5 years of experience in Quality Assurance and/or Clinical Research Development
Strong analytical skills and ability to draw conclusions from presented data
Ability to work effectively and efficiently in a dynamic environment with minimal supervision
High-level awareness and understanding of clinical trial regulations, including ICH-GCP and EU Clinical Trial Directive/Regulation
Knowledge of industry best practices
Flexibility to adapt to changing assignments and ability to prioritize effectively
Good project management, interpersonal, and communication skills
Ability to work independently and as part of a team
Willingness and ability to perform international travel

Benefits

Comp & perks

Paid time off (vacation, holidays, sick)
Medical, dental, and vision insurance
401(k)
Short-term incentive programs
International travel opportunities