Senior Compliance Auditor

3 weeks ago

North Chicago Illinois, United States AbbVie Full time
Job Description

Purpose

The Senior Audit and Compliance Auditor provides leadership, direction and perform evaluations for compliance with US and foreign regulation requirements and provide relevant and constructive evaluation of quality related systems for AbbVie plants, affiliates, functional areas and suppliers that provide materials, services and products to AbbVie. This includes API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Is also responsible for providing support to AbbVie plants in the resolution of regulatory issues and issues related to suppliers. Their leadership, direction and execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements to assure the quality, effectiveness and safety of our products.

Responsibilities

75% Travel

Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and AbbVie specifications.

Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.

The major responsibilities of this position are primarily focused on AbbVie facilities and key suppliers whose processes are more complex, comprehensive and critical to the business.

Lead or participating in more technically complex and strategic projects.

The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement, independence and objectivity.

Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards.

Collaborate with internal operations on quality issues at AbbVie facilities or those related to suppliers and in the resolution of supplier exceptions to AbbVie specifications. Auditing serves to provide feedback in the form of audit observations, formulation of recommendations, review of corrective actions and to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.

The position also provides an active role within the corporation as experts in GMP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.

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