Senior Auditor, GMP & Compliance - Quality Assurance Expert

AbbVie

Chicago (IL)

On-site

USD 110,000 - 150,000

Full time

5 days ago

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Job summary

AbbVie seeks a Senior Auditor, Audit and Compliance to perform comprehensive audits for regulatory compliance across AbbVie plants, affiliates, and suppliers. This role supports supplier QA audits and CAPA resolution to ensure GMP compliance and quality systems meet global requirements.

The position balances involvement with objectivity, working across procurement, SQA, EQA, and manufacturing teams, with up to 40% travel involved.

Qualifications

Bachelor’s Degree in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience.
9+ years of total relevant experience, including 6+ years in Quality Assurance with project management in pharmaceutical or related industry.
3+ years in compliance/auditing is required.
Travel up to 40%.

Responsibilities

Assesses compliance of systems, facilities, and procedures per applicable regulations and AbbVie specifications.
Provides feedback through audit observations and reviews corrective actions to verify effectiveness.
Collaborates with R&D QA to coordinate and conduct joint audits.
Ensures audits follow annual schedule and do not disrupt product supply.
Communicates audit activities with procurement, SQA, EQA, manufacturing sites, and affiliates.
Participates in strategic initiatives to improve regulatory and quality compliance.
For supplier audits, focuses on key suppliers and may participate in audits of AbbVie plants.
Maintains objectivity while providing actionable recommendations.