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Manager of Quality Assurance
2 months ago
The Opportunity
This position works out of our Abbott Park, IL location within the Abbott Quality and Regulatory Corporate Headquarters and/or any Abbott location for the right candidate. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering external inspections as related to Abbott's Quality System. This includes division / business support, quality/regulation expertise and consulting activities.
As the Manager of Quality Assurance, you’ll have the chance to provide leadership for pre-inspection, during inspection, and post inspection support. This support encompasses FDA inspections for the Nutrition, Medical Device, Diagnostics, and Pharmaceutical sectors within Abbott.
What You’ll Work On
Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program. Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third-party inspection (preparation, execution, and response). Provide direction and consultation for third-party inspections including the identification and review of outstanding issues, facilitating inspections, liaison training, and promoting effective and professional inspection facilitation. Capable of assessing, and providing meaningful feedback regarding compliance status, effectiveness of management teams, and related quality and operational systems. Provide scheduling and detailed project tasks for assigned sub-teams to ensure milestones are implemented. Review and support creative solutions to key topics and utilize risk management principles. Build and maintain a strategic focus on emerging regulations and their potential impact on Abbott is essential to success in this role.Required Qualifications
B.S. in Science or similar discipline 4-year degree in a technical or scientific discipline (Software Engineering a plus) Experience in Food and Drug Administration Inspections Candidates must have a sound fundamental understanding of regulatory inspections and quality systems.Preferred Qualifications
Ability to serve as a Technical Advisor, Consultant, or Subject Matter Expert including:Technical consultant to businessRepresent Abbott both internally and externally in key areasRecognized expert (and sought after) both internally and externally The following skills are preferred:Ability to have significant interaction with executive management with accountability for assigned projects.Proven technical project leader with an emphasis in Inspection Management and Regulations*
