Senior Manager

Job Description

Senior Manager Medical Affairs Quality Assurance is responsible for providing independent quality oversight of GxP activities executed by AbbVie's Medical Affairs enterprise, including but not limited to non-interventional studies, medical information and other regulatory commitments., covering the AbbVie drug, device and cosmetic portfolio.

The role reports to a Director of Safety, Vigilance and Medical Affairs Quality Assurance. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization at large.

Assures quality and compliance in a regulated environment that includes worldwide and country specific regulations and other applicable standards and AbbVie policies and procedures through review of compliance and quality system data.

Lead or participate in strategic initiatives to improve compliance to regulatory requirements and standards while positioning AbbVie for future success.

Contribute to a holistic quality assurance model for Medical Affairs, inclusive of internal and vendor performed activities. Partner with Medical Affairs and Epidemiology execute a proportionate quality assurance oversight model for non-interventional studies and regulatory commitments.

Promotes continuous education with regards to applicable regulations and expectations for self and other AbbVie staff.

Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance and support business process owners directly to ensure quality is integrated at all stages of process development.

Actively participate and lead front and back-room GxP inspection activities, with direct involvement that includes expert guidance to enable successful inspections with safety, RA and MA topics in scope.

Is recognized as a resource for consultation regarding worldwide MA and non-interventional research regulations and corporate policies, especially for CAPA and associated quality disciplines.