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.

Supervisor Quality Assurance Third Party Manufacturing

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

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:

• Training and career development , with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives, and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1

• Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays.

• Company Paid Pension Plan

• 401(k) retirement savings with a generous company match of 5%

• 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities.

The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division .

MAIN PURPOSE OF ROLE

• Implement, and maintain an effective Quality System within the Third-Party Manufacturing organization.

• Implement, and maintain an effective release process for Third Party Manufacturing and Warehouse sites. Manage the batch release team.

• Act as liaison with other departments on behalf of the Third-Party Manufacturing organization.

• Provide direction, support, leadership, and management of compliance to Federal Regulations, International Standards/Directives, or other applicable governing bodies and Abbott Policies as they relate to audits, quality systems, manufacturing, manufacturing support and CAPA management.

• Manage, lead, and develop individuals who can continually support a compliant environment.

What You’ll Work On

• Exercise independent, expert judgment to provide direction and management to all departments regarding risk and resolution.

• Serve as a strategic player, achieve a balance of involvement and objectivity, and prioritize for GMP compliance.

• Provide technical support as the area subject matter expert for Quality System /Compliance / Regulatory processes, procedures and issues. Keep current with regulatory requirements, proposals and best practices via constant surveillance of governmental publications, attending GMP/FDA seminars and meetings and disseminate regulatory requirements to appropriate personnel.

• Perform impact assessments on procedures and processes that are within or impact the Third-Party Manufacturing organization.

• Provide feedback (or direction), formulating recommendations and determining if corrective actions and commitments have been properly implemented and are effective.

• Monitoring metrics through Continuous Improvement Meetings, Annual Product Reviews and Quarterly Management Review Boards and weekly and monthly reports.

• Participate in or lead internal and external site audits as required.

• Coordinate and chair Quarterly Management Reviews to ensure the quality management system is suitable, adequate, and effective to meet the regulatory requirements and to support the established quality policies and objectives.

• Lead, develop, and coach Quality System team. This role has direct reports (3).

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required:

• Bachelor’s Degreean equivalent combination of education and work experience

• Minimum 2 years Regulatory, Compliance or Auditing experience

• Minimum 3 years Quality Assurance experience

MISC

• This is an onsite role not a remote role

• There is no relocation provided for this role

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 Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $83,000.00 – $166,000.00. 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