Senior Manager Quality Operations

Abbott • Carlsbad, CA

12d • Onsite

About The Position

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 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.

Requirements

• Bachelor’s degree in engineering or in life sciences or business.
• 10 years in Quality , Supply Chain and Manufacturing or related experience is .
• 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.

Nice To Haves

• Master’s Degree preferred.

Responsibilities

• 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 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level