Sr Manager Design Assurance - Nutrition at Abbott in Columbus, OH

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 107,000 colleagues serve people in more than 160 countries JOB DESCRIPTION: Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , Glucerna and ZonePerfect - to help get the nutrients they need to live their healthiest life. Our location in Columbus, OH, currently has an opportunity for a Sr Manager North America, Design Assurance. Our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life The North America Design Assurance Senior Manager must effectively develop, execute and manage the Quality Assurance Department in accordance with Corporate and Divisional policies and procedures in order to assure that proper controls are instituted and maintained. The manager must provide leadership for Global QA initiatives to implement quality systems/processes across Abbott Nutrition (AN) achieving quality improvements, cross plant consistency, and regulatory compliance. The manager is responsible for the use of strong, integrated, quality design principles to deliver innovation & support product lifecycle analysis at AN or third-party manufacturing sites. The manager has direct accountability for AN product quality, medical safety, and compliance to global regulatory requirements during design and development but also providing support on established products. This role requires ability to manage cross functional partnerships on new product introductions (avg. 40+ active projects at one time) and on-going product lifecycle management. The decision-making impact has direct result on AN division goals including margin (strategic cost improvement projects), sales (new innovation programs), and people (development & accountability). WHAT YOU'LL DO Effectively manage/develop the AN department staff to conduct quality assurance projects simultaneously to ensure that all operational, quality, & 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 Accountability / Scope / Budget Under the guidance of the Director of Quality Assurance, this position is responsible for compliance with Corporate and Divisional QA policies, procedures, standards and specifications as well as regulations in applicable countries of operation. Responsible for strategic innovations and lifecycle product quality management for 100+ different formulations out of any of the 6 NA manufacturing sites or 11 NA Third Party Manufactures. This position has budget responsibility. This position has direct reports up to 7 exempts and 2 non-exempts/contract employees. EDUCATION AND EXPERIENCE, YOU'LL BRING Required Education: Bachelor's degree in applied, physical, or life science, engineering or business. Master's degree preferred. A minimum of 10 years of experience in Quality, Supply Chain and Manufacturing, or related experience is required. Experience working with International plants and affiliates is preferred. Preferred Candidate must have demonstrated leadership skills/competencies with track record of success with no less than five years of supervisory management experience. 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) Expert knowledge of quality management systems and regulatory requirements. This position requires excellent problem solving and decision-making skills since the technology for many of Abbott's products are unique. This position requires a thorough understanding of integrated processes and technologies involved in supply management is required. The manager must have the ability to work and interact with many cultures in many time zones, and be capable of interpreting and analyzing technical data from different regions for decision making. The manager must have the ability to summarize and present technical recommendations and solutions to Abbott senior management WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer: 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 Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Salary Range: $150K -- $200K
Minimum Qualification
Life Sciences

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