The function of Senior Auditor, Audit and Compliance performs comprehensive audits for compliance with US and foreign regulation requirements, providing constructive evaluation of quality related systems for AbbVie plants, affiliates, quality service areas and/or suppliers that provide materials, services, and products to AbbVie. Responsible for providing support to AbbVie plants in the execution of supplier Quality Assurance Audits and the resolution of CAPA plans related to supplier Quality Assurance audits. Their 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 intended to assure the quality, effectiveness, and safety of our products. This position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.

Responsibilities

• Assesses compliance of systems, facilities, and procedures per applicable regulations, assuring compliance to regulatory requirements and AbbVie specifications.
• Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained at the supplier or internal AbbVie site. For internal sites, formulates recommendations for corrective actions.
• Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
• For supplier auditing, primarily focused on key suppliers whose processes are more comprehensive and critical to the business and will include potential participation in audits of AbbVie plants.
• Collaborates with R&D QA to coordinate and conduct joint audits.
• Communicates and coordinates supplier audit activities with internal stakeholders such as procurement, SQA, EQA, manufacturing sites and commercial affiliates as well as external stakeholders.
• Ensures audits are conducted according to the annual audit schedule.
• Ensures no product launch delays or business interruptions due to supplier audit delays thereby assuring of supply to AbbVie patients.