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Quality Assurance Program Manager

2 months ago

Pleasanton, California, United States Abbott Full time

Position Overview

This role is integral to our Quality and Regulatory Corporate Headquarters, focusing on the leadership and management of external inspections related to Abbott's Quality System. The Quality Program Manager will be responsible for providing strategic oversight and project management across various sectors, including Nutrition, Medical Device, Diagnostics, and Pharmaceuticals.

Key Responsibilities

  • Drive the advancement of the Inspection Readiness Program across Abbott.
  • Serve as a key partner in ensuring effective management of third-party inspections throughout their lifecycle, from preparation to execution and response.
  • Offer guidance and consultation for third-party inspections, including the identification of issues, facilitating inspections, and training liaisons to promote professional inspection management.
  • Evaluate compliance status and provide constructive feedback on the effectiveness of management teams and related quality systems.
  • Develop detailed project schedules and tasks for assigned teams to ensure timely achievement of milestones.
  • Review and endorse innovative solutions to critical 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 discipline or related field.
  • Four-year degree in a technical or scientific area, with a preference for Software Engineering.
  • Proven experience with Food and Drug Administration inspections.
  • Strong foundational knowledge of regulatory inspections and quality management systems.

Preferred Qualifications

  • Expertise in serving as a Technical Advisor or Consultant, recognized both internally and externally.
  • Demonstrated ability to engage with executive management on assigned projects.
  • Proven track record as a technical project leader, particularly in Inspection Management and Regulatory compliance.