Abbott Quality Program Manager- Quality Systems and Post-Market Surveillance in Abbott Park, Illinois
At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Primary Job Function:
The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott’s Quality System. This includes division / business support and quality expertise and consulting activities.
The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical and business support across all Quality Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the Divisions.
The Quality Program Manager will also serve as a primary subject matter expert in the area of worldwide Post-Market Surveillance. The candidate must possess knowledge and experience of all quality system requirements relative to post-market surveillance and will serve as the expert on the knowledge of post-market surveillance and vigilance reporting. The post-market surveillance SME must be able to interpret and apply regulatory and ISO requirements across multiple manufacturing sites and divisions globally (pharma, combination products, nutrition and device).
The candidate must be the able to:
• Understand and apply worldwide quality system requirements including post-market surveillance monitoring and reporting.
• Assist all Abbott businesses (pharma, nutrition and device) with the planning, preparation, review and evaluation of quality data reports, and other (e.g. periodic safety update and trend) reporting requirements.
• Review and make recommendations related to Abbott Quality Systems policy and procedures, including post-market surveillance and vigilance reporting.
• Deliver various levels of training on the Abbott Quality Systems, including post-market surveillance and vigilance reporting.
• Provide technical and consulting support to Abbott businesses in all areas of the Abbott Quality Systems, including post-market surveillance monitoring and reporting.
• Facilitate and work towards program standardization between various Abbott businesses and divisions in the quality systems, including post-market surveillance.
• Lead and facilitate implementation of changes to regulations or new regulations, within the area of expertise, throughout the corporation.
Travel, domestic and international, may be up to 75%.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Lead global committees and teams
Provide direct business support
Participation in industry groups
Improve the effectiveness of the Abbott Quality System, including monitoring, trending and analysis of Abbott’s compliance performance
Act as a change agent for incorporating best practice methods
Liaison to Divisions on the Quality System.
Position Accountability / Scope:
The scope of this position is Abbott-wide, covering all Abbott divisions / businesses.
This position manages multiple global projects.
Given the nature of the projects as they relate to regulatory 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.
Significant interaction with executive management with accountability for assigned projects.
4-year degree in a technical or scientific discipline.
Minimum Experience / Training Required:
Managerial/Supervisory Experience – At least 4 years
Quality Assurance and/or Compliance and/or Manufacturing and/or Operations and/or Regulatory Compliance - 10 years
This position can be hired as a grade 18-20, depending on the selected candidates experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org