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Quality Assurance Program Manager
2 months ago
The Role
This position is integral to our operations, focusing on the leadership and management of quality assurance initiatives across various sectors. The Quality Assurance Program Manager is responsible for overseeing external evaluations in alignment with our comprehensive Quality System. This role requires collaboration with different divisions and offers expertise in quality and regulatory matters.
As the Quality Assurance Manager, you will play a pivotal role in guiding activities before, during, and after inspections. This includes supporting inspections from regulatory bodies across Nutrition, Medical Devices, Diagnostics, and Pharmaceuticals.
Key Responsibilities
Lead and enhance the Abbott-wide Inspection Readiness Program. Serve as a strategic collaborator to ensure business locations effectively manage the entire process of third-party inspections, from preparation to execution and response. Provide expert guidance for third-party inspections, including identifying and addressing outstanding issues, facilitating inspections, and conducting training for effective inspection management. Evaluate and deliver insightful feedback on compliance status, management effectiveness, and related quality and operational systems. Organize and detail project tasks for assigned teams to ensure timely achievement of milestones. Analyze and support innovative solutions to critical issues while applying risk management principles. Maintain a strategic perspective on emerging regulations and their implications for Abbott's operations.Required Qualifications
Bachelor’s degree in a scientific discipline or related field. Four-year degree in a technical or scientific area (Software Engineering is advantageous). Experience with Food and Drug Administration inspections. Strong foundational knowledge of regulatory inspections and quality systems is essential.Preferred Qualifications
Ability to act as a Technical Advisor, Consultant, or Subject Matter Expert, including: providing technical consultation to the business and representing Abbott in key areas. Recognized expertise both internally and externally, with significant interaction with executive management regarding project accountability. Proven leadership in technical projects, particularly in Inspection Management and Regulatory compliance.