Quality Assurance Program Manager

1 week ago


Pleasanton, California, United States Abbott Full time

Position Overview

This role is situated within the Abbott Quality and Regulatory Corporate Headquarters, focusing on providing leadership and oversight for external inspections related to Abbott's Quality System. The Quality Program Manager is responsible for project management and support across various divisions, ensuring compliance and regulatory expertise.

As the Quality Assurance Manager, you will play a pivotal role in leading efforts before, during, and after inspections. This includes managing FDA inspections across Abbott's Nutrition, Medical Device, Diagnostics, and Pharmaceutical sectors.

Key Responsibilities

  • Lead and enhance the Abbott-wide Inspection Readiness Program.
  • Serve as a strategic partner to ensure effective management of third-party inspections throughout their lifecycle.
  • Provide guidance and consultation for third-party inspections, including issue identification, inspection facilitation, and training.
  • Assess compliance status and offer constructive feedback on management effectiveness and quality systems.
  • Organize scheduling and detailed project tasks for assigned teams to meet critical milestones.
  • Evaluate and support innovative solutions to key issues while applying risk management principles.
  • Maintain a strategic focus on emerging regulations and their implications for Abbott's operations.

Required Qualifications

  • Bachelor’s degree in a scientific or related field.
  • Four-year degree in a technical or scientific discipline, with a preference for Software Engineering.
  • 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 or Subject Matter Expert, representing Abbott in key areas.
  • Proven experience in interacting with executive management and leading technical projects focused on Inspection Management and Regulations.


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