Quality Operations Manager

Abbott•Columbus, OH

1d•$129,300 - $258,700•Onsite

About The Position

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 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 – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 5 personal days + 10 paid holidays Retiree Healthcare program Robust 401(k) retirement savings with a generous company match 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 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.

Requirements

Bachelor’s degree in a scientific or technical discipline
7+ years of experience in Quality, Manufacturing, or a related technical field within a regulated environment.
4+ years of direct supervisory or people leadership experience.
Demonstrated subject matter expertise in Quality Systems, documentation control, compliance, and product release processes.
Strong decision making ability 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 relationship building skills within plant operations and cross functional teams.
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 to maintain composure and sound judgment in a fast paced environment.

Nice To Haves

Master’s degree in a scientific or technical discipline.
Experience supporting or leading Quality functions in a high volume manufacturing facility.
Experience participating in or leading cross division or enterprise level quality initiatives.

Responsibilities

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 end to end batch documentation review, evaluating compliance, CAPA, interventions, and environmental monitoring data prior to batch release.
Own the Batch Release process, managing nonconformances, initiating corrective actions, controlling product release, and coordinating quarantine of nonconforming product.
Develop and monitor key quality metrics to track compliance, operational performance, and QMS effectiveness, using data to identify trends 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 and participate as a member of the site senior leadership team.
Select, train, develop, and mentor QA staff to support current and future business needs and all elements of the QMS.
Develop and maintain a 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 customer complaints; 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 divisional objectives while upholding Abbott’s Code of Conduct and high standards of communication and professional behavior.
Drive strong customer service within QA processes while maintaining regulatory and quality compliance.
Support cost improvement initiatives and division driven 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 changes deliver per agreed project timelines and quality expectations.

Benefits

Production areas that are clean, well-lit and temperature-controlled
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 – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 5 personal days + 10 paid holidays
Retiree Healthcare program
Robust 401(k) retirement savings with a generous company match
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 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.