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Senior Manager Quality Business Support (North Chicago)

Senior Manager Quality Business Support (North Chicago)

Abbott Laboratories companyNorth Chicago, IL, US
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Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. Youll 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 a high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
  • A company recognized as a great place to work in dozens of countries worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Abbott Park, IL facility.

The function of the Senior Manager Quality Business Support is to provide leadership, oversight, and project management covering Abbott's 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 the subject matter of the position. The incumbent should also have a working knowledge of related Quality System elements, e.g., Medical Device Reporting, Nonconformances & CAPA, Design Controls, etc. This position works out of our Abbott Park location or other Abbott locations in the Abbott Quality and Regulatory (AQR) division.

What Youll Work On

  • 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.
  • Direct reports could include 0-3 individuals. Indirect reports could include 0-3 individuals.
  • The scope of this position is Abbott-wide, covering all Abbott Businesses / Divisions.
  • The position manages multiple global projects, partnering with business units to improve their overall compliance and profile through assessment and remediation / continuous improvement efforts.
  • 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 and key stakeholders across the corporation and accountability for assigned projects.
  • Required Qualifications

  • 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.
  • Former Regulatory Body (eg. FDA, MHRA, Notified Body) experience preferred
  • In addition, 3 years of project management experience (certification is preferred, but not required) is preferred.
  • Total combined minimum years of industry experience required : 10-12 (not necessarily the sum of the above).
  • Travel :

  • 50% of the time
  • Apply Now

    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.

    Connect with us at www.abbott.com, on Facebook at www.facebook.com / Abbott, and on Twitter @AbbottNews.

    The base pay for this position is $127,300.00 $254,700.00. In specific locations, the pay range may vary from the range posted.

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