Quality Program Manager - Production and Process Controls SME

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. ## **JOB DESCRIPTION:** **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. - 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 high employer contribution - Tuition reimbursement, the [Freedom 2 Save](https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and [FreeU](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 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** This position works out of our Abbott Park, IL location within the AQR Abbott Quality Regulatory division. The function of the Quality Program Manager is to provide leadership, oversight, and project management covering Abbott’s Quality Management System. This includes division / business support and quality expertise and consulting activities. The Quality Program Manager will support Divisions across all Abbott Quality Systems in activities associated with quality, regulatory compliance areas. The candidate will provide strategic, technical, and business support across all Quality Management Systems by interacting directly with Divisions and providing quality and technical expertise and strategic consulting activities for the Divisions. The Quality Program Manager will also serve as a primary subject matter expert and owner of corporate policies in the areas of Production and Process Controls. The candidate must possess knowledge and experience of all quality management system requirements related to corporate policy and will serve as the expert on the knowledge of Production and Process Controls and how it interfaces with other areas of product quality subsystems and the Total Product Lifecycle development process. The SME must be able to interpret and apply world-wide regulatory and ISO requirements across multiple manufacturing sites and divisions globally (pharma, combination products, nutrition, and device) The Quality Program Manager will also understand and apply global regulatory requirements (e.g., 21 CFR 820, ISO 13485) related to production and process controls, including Equipment Qualification and Process Validation, manufacturing operations and monitoring systems. **What You'll Work On:** - Assist all Abbott businesses (pharma, nutrition and device) with the planning, design, implementation, review and continuous improvement of manufacturing processes, including validation planning and strategy. - Lead cross-functional initiatives to improve process capability, robustness, and compliance, using data-driven methods and risk management tools (e.g., FMEA, SPC). - Review and provide recommendations on process and equipment qualifications, including: - Process and equipment user requirement - Equipment qualification (IQ/ OQ/PQ) - Process Validation and Revalidation - Cleaning validation - Physical and Analytical Test Method Validation - Maintain subject matter exper…