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Auditor, RDQA Clinical Quality Audit - Remote

AbbVie · Florham Park, NJ

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Clinical OperationsFull timeCompany career page

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Role summary

AbbVie seeks a Clinical Quality Auditor to manage the execution of clinical audit programs, including scheduling, planning, and reporting. The role involves ensuring compliance with regulations and company policies while supporting the quality assurance system and providing guidance on GCP requirements to business partners.

What they're looking for

  • Bachelor's degree in science, healthcare profession, or equivalent experience
  • 3-5 years in biopharmaceutical industry or regulatory authority
  • 3-5 years in quality assurance and/or clinical research development
  • Strong analytical skills with ability to interpret data and draw conclusions
  • Demonstrated knowledge of clinical trial regulations including ICH-GCP
  • Effective project management, communication, and interpersonal skills
  • Willingness to travel internationally up to 40% of the time

What you'll be doing

  • Execute and oversee clinical audit scheduling, planning, and conduct activities
  • Assess compliance with regulations, guidelines, policies, and sponsor requirements
  • Communicate audit results orally and in writing within established timeframes
  • Review, approve corrective action plans, and track completion of remediation actions
  • Contribute to development and maintenance of quality systems and clinical audit standards

Privacy & handoff

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What RoleLantern checked

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RoleLantern checkedNeeds clarity
Date posted2 days ago
Last source checkToday
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