Senior Manager Quality Operations

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.

Senior Manager Quality Operations

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 :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
  
  

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry‑leading technologies to support diagnostic testing that provides critical information for the treatment and management of diseases and other health conditions. Our solutions empower clinicians, patients, and communities with timely, reliable insights that drive better health outcomes around the world.

About The Role

We are seeking a Senior Manager, Quality Operations to join our dynamic Infectious Disease team in Carlsbad, California. In this leadership role, you will guide a high‑performing quality organization, ensure compliance with global regulatory requirements, and enable the delivery of safe, effective, and innovative diagnostic products. You’ll play a key role in shaping quality strategy, driving continuous improvement, and fostering a culture of operational excellence across the site.

The Opportunity

The Senior Manager, Quality Operations is responsible for ensuring consistently high product quality while driving operational efficiency, leading the Quality Assurance function in alignment with Corporate and Divisional policies and regulatory requirements. This role develops, executes, and oversees quality systems and processes that strengthen controls, improve quality performance, and drive cross‑plant consistency across the organization. In addition, the Senior Manager provides strategic leadership for global QA initiatives and serves as the final authority for all product‑related decisions, including acceptance, release, and post‑production assessments, investigations, and complaint management.

What You’ll Work On

• Effectively manage/develop the department staff to conduct quality assurance projects simultaneously to ensure that all operational & compliance aspects meet planned dates.
• Ensure department programs and quality system documents meet corporate and regulatory requirements to provide sufficient oversight to avoid regulatory vulnerability and regulatory action.
• Support plant quality assurance, operations and purchasing groups globally to ensure that proper incoming material documentation (CAPA, acceptance plans and specifications) are compliant to Corporate, Division, and regulatory requirements.
• Reviews performance of the department and personnel against approved objectives, budgets and plans, and takes necessary remedial actions.
• Insures that required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, regulatory inspections are maintained.
• Manage the department operating model to support the program execution, performance monitoring and continuous improvement processes.
• Execute the qualification of products to assure that Division programs and initiatives are met.
• Provide operational support to division global operations by conducting event management.
• Utilize monitoring policies and procedures to assure that all products generated conform to predetermined Corporate/Division standards and specifications.
• Creates, implements, and/or supports development programs for the continuous improvement of vendors to achieve sustainable performance which meets Division requirements.
• Engages in cross functional partnerships on new product introductions/innovations which drive business growth and/or compliance initiatives
  
  

Required Qualifications

• Bachelor’s degree in engineering or in life sciences or business.
• 10 years in Quality, Supply Chain and Manufacturing or related experience is required.
• 5 years of supervisory management experience.
• 3 years in a GMP environment. 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).
• 3 years working with quality management systems and regulatory requirements.
• Proven performance in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Strong project management and people leadership skills.
  
  

Preferred Qualifications

• Master’s Degree preferred.
  
  

Apply Now

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.

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The base pay for this position is $148,700.00 – $297,300.00. In specific locations, the pay range may vary from the range posted.