At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
The function of the Quality Program Manager is to provide leadership, oversight, and project management covering the Abbott Quality System. This includes Business / Division support, quality expertise and consulting activities globally. The incumbent must have a working knowledge of global regulations and industry standards related to Quality Systems elements, e.g., Design Controls, Change Control, Medical Device Reporting, Nonconformances and CAPA, etc.
Core Job Responsibilities
Lead global committees and teams. Provide direct Business / Division support. Participate in industry groups. Improve the effectiveness of the Abbott Quality System, including monitoring, trending and analysis of Abbott compliance performance. Act as a change agent for incorporating best practice methods. Act as Divisional liaison to AQR.
Supervisory / Management Responsibilities
Direct reports could include 0-3 individuals. Indirect reports could include 0-3 individuals.
Position Accountability / Scope
The scope of this position is Abbott-wide, covering all Abbott Businesses / Divisions.
This position manages multiple global projects.
Given the nature of the projects as they relate to regulatory and quality compliance, the financial consequences for adverse regulatory findings or delayed product approval initiatives range from $10MM to $50MM.
This position manages confidential information across the project lifecycle.
This position requires significant interaction with executive management with accountability for assigned projects.
Minimum Education: Bachelor’s Degree required; Life or Engineering Sciences discipline, preferred.
Minimum Experience / Training Required: 4 years in Quality Assurance and/or Compliance managerial, supervisory or SME role; plus 10 years in Medical Device, Pharmaceutical and/or Nutritional industry professional-level position. In addition, 3 years of project management experience (certification is preferred, but not required). Total combined minimum years of industry experience required: 10-12 (not necessarily the sum of the above).
AQR Abbott Quality and Regulatory
United States > Abbott Park : AP52 Floor-1
Yes, 50 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf