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 115,000 colleagues serve people in more than 160 countries.
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.
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. You'll also have access to:
Production areas that are clean, well-lit and temperature-controlled
Training and career development , with onboarding programs for new employees and tuitionassistance
Financial security through competitive compensation,incentivesand retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
Vacation - 120 hours of accrued vacation (1 st yr is prorated) + vacation buy program + 5personal days + 10 paid holidays
Retiree Healthcare program
Robust 401(k) retirement savings with a generous company match
Tuition reimbursement, theFreedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debtprogramandFreeU (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 asa great placeto work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A stable?company with a record of strong financial performance and history of being actively involved in local communities
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 Role
The Quality Operations Manager provides strategic leadership for all quality documentation, batch release, and compliance activities within the Columbus manufacturing site. This role ensures the integrity of the site's Quality Management System (QMS) while guiding QA teams to deliver safe, compliant products that meet Abbott and regulatory standards.
WHAT YOU'LL DO
Manage QA teams responsible for quality documentation accuracy, batch record review, and product release within a manufacturing environment.
Implement,maintain, and continuously improve the site Quality Management System (QMS) to ensure compliance with Abbott policies, divisional requirements, and applicable regulatory standards.
Lead endtoend batch documentation review, evaluating compliance, CAPA, interventions, and environmental monitoring data prior to batch release.
Own the Batch Release process, managing nonconformances,initiatingcorrective actions, controlling product release, and coordinating quarantine of nonconforming product.
Develop andmonitorkey quality metrics to track compliance, operational performance, and QMS effectiveness, using data toidentifytrends and drive continuous improvement.
Review and approve site documentation change requests, assess corporate/divisional policy updates, and ensure aligned change control across impacted functions.
Support new product introductions, ensuring documentation, label copy adherence, training, and certification requirements are met.
Maintain the site documentation and QA Work Order systems, ensuring documents meet Abbott and regulatory standards and are stored in compliant, efficient systems.
Serve as the site Quality System Management Representative andparticipateas a member of thesitesenior leadership team.
Select, train, develop, and mentor QA staff to support current and future business needs and all elements of the QMS.
Develop andmaintaina culture where Health & Safety is an individual and collective responsibility; address H&S concerns and reduce risk within areas of responsibility.
Manage CAPA processes including nonconformances, audit findings, and customercomplaints;support field action activities when applicable.
Ensure compliance with applicable local and international regulations for markets served, including evaluation of new regulations and their impact on the business.
Lead QA personnel to achieve site and divisionalobjectiveswhile upholding Abbott's Code of Conduct andhigh standardsof communication and professional behavior.
Drive strong customer service within QA processes whilemaintainingregulatory and quality compliance.
Support costimprovement initiatives and divisiondriven programs without compromising quality or compliance.
Manage QA resource planning and associated budget requirements (expense and capital).
Partner with functional groups to ensure new products and changesdeliverper agreed project timelines and quality expectations.
REQUIRED QUALIFICATIONS
Bachelor's degree ina scientificor technical discipline
7+ years of experience in Quality, Manufacturing, or a related technical field within a regulated environment.
4+ years of direct supervisory orpeopleleadership experience.
Demonstrated subject matterexpertisein Quality Systems, documentation control, compliance, and product release processes.
Strongdecisionmakingability with proven experience evaluating risk and business impact with limited information.
Ability to lead and contribute to quality initiatives, system improvements, and organizational development efforts.
Ability to work effectively in a highly matrixed organization and partner across functions.
Strong interpersonal, collaboration, and relationshipbuilding skills within plant operations andcross functionalteams.
Excellent verbal and written communication skills, with the ability to communicate clearly at multiple levels in the organization.
Strong organizational skills with the ability to multitask, prioritize, and meet deadlines.
Demonstrated professionalism and ability tomaintaincomposure and sound judgment in afastpacedenvironment.
PREFERRED QUALIFICATIONS
Master's degree ina scientificor technical discipline.
Experience supporting or leading Quality functions in ahighvolumemanufacturing facility.
Experienceparticipatingin or leading crossdivisionor enterpriselevel quality initiatives.
Apply Now (https://www.jobs.abbott/us/en)
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Pre-Employment Inquiries and Citizenship | U.S. Equal Employment Opportunity Commission (eeoc.gov) (https://www.eeoc.gov/pre-employment-inquiries-and-citizenship)
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)
*Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
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 and a Military/Veteran friendly Employer, committed to employee di
The base pay for this position is $129,300.00 - $258,700.00. 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
