Manager of Quality Assurance

at Abbott in Abbott Park, Illinois, United States

Job Description

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 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

+ Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

+ An excellent retirement savings plan with high employer contribution

+ Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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 within the Abbott Quality and Regulatory Corporate Headquarters. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering external inspections as related to Abbott’s Quality System. This includes division / business support, quality/regulation expertise and consulting activities.

As the Manager of Quality Assurance, you’ll have the chance to provide leadership for pre-inspection, during inspection, and post inspection support. This support encompasses FDA inspections for the Nutrition, Medical Device, Diagnostics, and Pharmaceutical sectors within Abbott.

What You’ll Work On

+ Provide leadership and direction for furthering the development of the Abbott-wide Inspection Readiness Program.

+ Act as a strategic partner for ensuring that our business locations are effective in the full life cycle of a third-party inspection (preparation, execution, and response).

+ Provide direction and consultation for third-party inspections including the identification and review of outstanding issues, facilitating inspections, liaison training, and promoting effective and professional inspection facilitation.

+ Capable of assessing, and providing meaningful feedback regarding compliance status, effectiveness of management teams, and related quality and operational systems.

+ Provide scheduling and detailed project tasks for assigned sub-teams to ensure milestones are implemented.

+ Review and support creative solutions to key topics and utilize risk management principles.

+ Build and maintain a strategic focus on emerging regulations and their potential impact on Abbott is essential to success in this role.

Required Qualifications

+ B.S. in Science or similar discipline

+ 4-year degree in a technical or scientific discipline (Software Engineering a plus)

+ Experience in Food and Drug Administration Inspections

+ Candidates must have a sound fundamental understanding of regulatory inspections and quality systems.

Preferred Qualifications

+ Ability to serve as a Technical Advisor, Consultant, or Subject Matter Expert including:

+ Technical consultant to business

+ Represent Abbott both internally and externally in key areas

+ Recognized expert (and sought after) both internally and externally

+ The following skills are preferred:

+ Ability to have significant interaction with executive management with accountability for assigned projects.

+ Proven technical project leader with an emphasis in Inspection Management and Regulations

Apply Now (https://www.jobs.abbott/us/en)

• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar 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 (http://www.abbottbenefits.com/pages/candidate.aspx)

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 X (formerly Twitter) @AbbottNews and @AbbottGlobal.

The base pay for this position is $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.

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 corpjat@abbott.com