Compliance Readiness Quality Assurance - Nutrition - Columbus, OH/AN Manufacturing Sites
Company: Abbott Laboratories
Posted on: November 19, 2022
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
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
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
This position works out of our Columbus, Ohio location in the
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
* 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
* Liaises with interdivisional team in external audit community of
practice and manage external audit lifecycles with AQR to close all
* Assists with food facility registrations and work with Regulatory
Affairs and sites to ensure registration submissions are timely and
EDUCATION AND EXPERIENCE, YOU'LL BRING
* 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.
* 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
* 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
* 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
* Able to effectively manage project resources and stakeholder
* 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
* Possess excellent communication and interpersonal skills
* Proficient in MS Office such as Outlook, Word, Excel, PowerPoint,
* 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:
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
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
Keywords: Abbott Laboratories, Fairfield , Compliance Readiness Quality Assurance - Nutrition - Columbus, OH/AN Manufacturing Sites, Other , Fairfield, California
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