Senior Manager Quality Assurance

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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 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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with 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 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 Opportunity

The Operations Quality Assurance Manager will work out of the Irving, TX location.

The Operations Quality Assurance Manager must effectively develop, execute, and manage the Quality Assurance Department following Corporate and Divisional policies and procedures to assure that proper controls are instituted and maintained. The manager has overall responsibility for maintaining high-quality levels on all products while achieving high efficiency. The manager must provide leadership for Global QA initiatives to implement quality systems/processes across the organization and Division, achieving quality improvements, cross-plant consistency, and regulatory compliance. The manager has final authority for product-related decisions, including acceptance, release, and post-production assessment, and events or complaints.

What You’ll Work On:

The Operations Quality Assurance Manager is responsible for:

• Managing and developing department staff to handle multiple quality assurance projects simultaneously, ensuring all operational and compliance aspects meet planned deadlines.
• Ensuring department programs and quality system documents comply with corporate and regulatory requirements, providing sufficient oversight to avoid regulatory vulnerabilities and actions.
• Supporting plant quality assurance, operations, and purchasing groups globally to ensure incoming material documentation (CAPA, acceptance plans, and specifications) meets Corporate, Division, and regulatory standards.
• Reviewing department and personnel performance against approved objectives, budgets, and plans, and taking necessary remedial actions.
• Maintaining required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, and regulatory inspections.
• Managing the department's operating model to support program execution, performance monitoring, and continuous improvement processes.
• Executing product qualifications to ensure Division programs and initiatives are met.
• Providing operational support to the division's global operations by conducting event management.
• Utilizing monitoring policies and procedures to ensure all products conform to predetermined Corporate/Division standards and specifications.
• Creating, implementing, and supporting development programs for continuous vendor improvement to achieve sustainable performance that meets Division requirements.
• Engaging in cross-functional partnerships on new product introductions and innovations, driving business growth and compliance initiatives.

Education, Skills, Experience:

Required Qualifications

• Bachelor’s degree in physical or life science, engineering, or business.
• 10 years of experienc