Auditor, RDQA Clinical Quality Audit - Remote
AbbVie · North Chicago, IL
Clinical OperationsFull timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Clinical quality auditor responsible for executing the audit program, including scheduling, planning, and reporting on clinical processes. Role involves assessing compliance with global regulations and AbbVie policies while providing consultation on GCP requirements to business partners.
What they're looking for
- Bachelor's degree in science, health care profession, or equivalent experience
- 3-5 years biopharmaceutical industry or regulatory authority experience
- 3-5 years quality assurance and/or clinical research development experience
- Strong analytical skills with ability to interpret data and draw conclusions
- Deep knowledge of clinical trial regulations including ICH-GCP and EU directives
- Project management, interpersonal, and communication skills
- Willingness to travel internationally
What you'll be doing
- Execute clinical audit program activities including scheduling, planning, and conducting audits
- Assess compliance with regulations, guidelines, policies, and sponsor requirements across audit types
- Communicate audit findings orally and in writing within established timeframes
- Review and approve corrective action plans and track completion of remedial actions
- Contribute to quality system development and continuous improvement initiatives
Privacy & handoff
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