AQR Quality Program Manager

Working at Abbott

• At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Abbott Park, IL location for our AQR Abbott Quality and Regulatory division.

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 and owner of corporate policies in the areas of Buildings, Facilities and Utilities and Material Controls.   The candidate must possess knowledge and experience of all quality system requirements relative to corporate policy and will serve as the expert on the knowledge of environmental and manufacturing clean rooms and how it interfaces with other areas of product quality subsystems and the Total Product Lifecycle development process.  The SME must be able to interpret and apply world-wide 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 environmental and clean room requirements to manufacturing, and monitoring.
• Assist all Abbott businesses (pharma, nutrition and device) with the planning, preparation, review and evaluation of environmental and clean room designs, operations, and validations.
• Review and make recommendations related to environmental and clean room qualifications, including design, installation, operational, and performance
• Deliver various levels of training on the Abbott Quality Systems, on environmental and clean room operations.  Participate the Validation Community of practice.
• Provide technical and consulting support to Abbott businesses in the areas of environmental and clean room operations, monitoring and validation.
• Facilitate and work towards program standardization between various Abbott businesses and divisions.
• Experience in following industries is acceptable:  Medical Devices, Pharmaceuticals, Healthcare, Electronics/High Tech (i.e. clean room manufacturing such as integrated circuit engineering or production.)

What You’ll Work On

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.

Preferred Qualifications

• 4-year degree in a technical or scientific discipline.
• Minimum Experience / Training Required:
• Managerial/Supervisory Experience – 4 years or greater preferred
• Quality Assurance and/or Compliance and/or Analytical Laboratories and/or Manufacturing and/or Operations - 10 year

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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