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AbbVie is a global pharmaceutical company focused on discovering, developing, and delivering medicines for complex health conditions. Its portfolio spans immunology, oncology, neuroscience, and aesthetics, with operations serving patients in more than 175 countries. The company’s work combines pharmaceutical research, manufacturing, and healthcare expertise, supported by substantial investment in scientific innovation and research and development. AbbVie also highlights diversity, sustainability, and patient support as part of its broader approach to improving health outcomes and community impact.
AbbVie Clinical Quality Auditor RDQA Remote Illinois
Conduct AbbVie’s global clinical audit program for innovative medicines. Support GCP compliance, audit resolution, and continuous improvement of clinical quality systems.
Description
- Manage Clinical audit scheduling, planning, reporting, and resolution activities
- Apply RDQA policies and procedures across clinical quality work
- Help develop and implement the Clinical QA quality system
- Advise business partners on GCP and clinical quality matters
- Assess clinical processes through audits and quality oversight activities
- Lead and support Clinical Audit planning, scheduling, and execution
- Perform investigator site, process, system, and Affiliate audits
- Deliver written and verbal audit results within required timelines
- Review and approve Corrective Action Plans and monitor their completion
- Help implement systems and processes that support global quality assurance requirements
- Maintain and develop standards for Clinical audit activities
- Support continuous improvement initiatives and related projects
- Participate in and support GCP inspections as needed
- Provide GCP regulatory guidance and consultation to RDQA and business partners
- Promote ongoing education on quality, clinical guidelines, and regulations
Requirements
- Bachelor’s degree in physical, life, or health sciences, a healthcare profession such as nursing or pharmacy, or equivalent experience
- Three to five years of experience in the biopharmaceutical industry or with a regulatory authority
- Three to five years of experience in Quality Assurance and/or Clinical Research Development
- Strong analytical ability with the judgment to draw conclusions from data
- Ability to work efficiently in a dynamic environment with minimal supervision
- Working knowledge of clinical trial regulations, including ICH-GCP and the EU Clinical Trial Directive or Regulation
- Understanding of industry best practices
- Adaptability to changing assignments and effective prioritization skills
- Strong project management, interpersonal, and communication skills
- Ability to work independently and collaboratively
- Willingness and ability to travel internationally
Benefits
- Paid vacation, holidays, sick leave, and other time off
- Medical, dental, and vision coverage
- 401(k) retirement plan
- Short-term incentive programs
- Opportunities for international travel
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