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Compliance Readiness Quality Assurance - Nutrition - Columbus, OH/AN Manufacturing Sites

Company: Abbott Laboratories
Location: Fairfield
Posted on: November 19, 2022

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 113,000 colleagues serve people in more than 160 countries.

Compliance Readiness Quality Assurance

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 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 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, Ohio location in the Nutrition Division.

What You'll Work On

Divisional Strategic Inspection/Audit Support Management

* Reporting to the QA Manager Strategic Readiness, supports regional program for inspections/audit readiness. Establishes and maintain divisional procedural requirements for external audit support and processing.
* Utilizes ANQA strategic direction and data to develop audit readiness strategies, communication plan etc. per site as audit preparation. With sites, prepare audit preparation plans and assist in execution of the plans.
* Work with the sites and other functional groups to determine best in class replication opportunities within the Quality systems. Partner with the sites through assessments and simulations to determine and mitigate areas of high risks.
* Assists the sites, in coordination with quality system owners, in remediating and establishing action plans on critical and major audit findings.
* Overall responsibility is to assure that the AN global Quality system is effective in accordance with FDA, ISO and country specific requirements as well as AQR global policies.
* Assists in assuring that Quality System Owner Program and corresponding cadence of governance are established and effective in assuring robust quality system impact assessment to mitigate recurrence of compliance and product risk.
* Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.
* Assists in reviewing Global Quality System health for improvements and opportunities. Develop insights, short term, and long-term goals to sustain Quality system health improvements.
* Assists in onboarding new Quality System Owners and Compliance Officers.
* Liaises with interdivisional team in external audit community of practice and manage external audit lifecycles with AQR to close all audits.
* Assists with food facility registrations and work with Regulatory Affairs and sites to ensure registration submissions are timely and accurate.

EDUCATION AND EXPERIENCE, YOU'LL BRING

Required:

* Education: Bachelor's degree in applied, physical, or life science, engineering or business. Master's degree preferred.
* A minimum of 5 years of experience in Quality, Research and Development (R&D), Supply Chain and Manufacturing, regulatory and quality audits/inspections, or related experience is required. Experience working with sites, R&D, supplier, TPM, regulatory and affiliates is preferred.

Preferred:

* Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience.
* Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP)
* Expert knowledge of quality management systems and regulatory requirements.
* This position requires excellent problem solving and decision-making skills since the technology for many of Abbott's products are unique.
* This position requires a thorough understanding of integrated processes and technologies involved in supply management is required.
* The post holder must have the ability to work and interact with many cultures in many time zones and be capable of interpreting and analyzing technical data from different regions for decision making. The post holder must have the ability to summarize and present technical recommendations and solutions to Abbott senior management
* Able to effectively manage project resources and stakeholder management
* High customer orientation and sense of ownership and strong focus on business outcomes
* Able to make decisions that impact project level activities and influence project level budget
* Able to interact and contribute effectively with others in a team
* Possess excellent communication and interpersonal skills
* Proficient in MS Office such as Outlook, Word, Excel, PowerPoint, Power Bi.

Apply Now

* 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

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.

Keywords: Abbott Laboratories, Fairfield , Compliance Readiness Quality Assurance - Nutrition - Columbus, OH/AN Manufacturing Sites, Other , Fairfield, California

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