Director, Preclinical Quality Assurance

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 su...