Primarily responsible for ensuring adherence to GLP regulations and developing an organizational model for the global Quality Assurance Unit. Manage a team of audit professionals responsible for quality oversight of all non-clinical GLP and GCP regulated studies.

Responsibilities

• Management of the Preclinical Quality Assurance Team including the Preclinical QA Audit Program. Ensure adherence to GLP and GCP laboratory regulations. Collaborate with GXP Vendor Compliance to ensure all external vendors, who provide materials and services on behalf of AbbVie, are appropriately approved priorto use.

• Develop an organizational model for internal GLP audit coverage and ensure appropriate capabilities and resources exist.

• Consultation with Test Facility Management, Study Directors and Principal Investigators regarding GLP and laboratory GCP requirements. Advocate for Quality standards and clearly and logically justify such positions to be seen as a subject matter expert and advisor.

• Evaluation of new respectively revised regulatory or legal requirements as they apply to non-clinical laboratories including study activities. Where applicable, initiation of implementation in the R&D Quality System.

• Attend Peer Industry working groups on relevant topics in GLP, GCP and other laboratory relevant regulatory guidance’s. conduct of industrial benchmarking.

• Define quality goals for both annual and long-range plans. Work with management and department personnel to achieve goals and strategic initiatives.

• Support the Pre-Clinical Due Diligence activities program for RDQA. Work with Business Development to ensure appropriate cross-functional assessment of targeted asset(s) and consolidate all RDQA Due Diligence findings for communication/recommendation to Business Development.

• Conduct functional area management review; prepare appropriate metrics and present significant events to senior management.

• Define and execute goals and personnel development plans within the group. Provide annual performance reviews for direct reports. Recommend hiring, promotion and disciplinary action for staff.