Program Manager - Columbus, OH

Abbott • Columbus, OH

12h

About The Position

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 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®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives. 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 will also have access to: 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, Medical Benefits start day 1. Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 5 personal days + 10 paid holidays. 401(k) retirement savings with a generous company match of 5%. 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities. The Program Manager, Design Assurance role has the broad objective of assuring the quality of design and development through manufacture and distribution for all products in the Abbott Nutrition portfolio. The successful incumbent will require the ability to appropriately identify, assess and minimize risks in the design of products to assure the safety, efficacy, regulatory compliance and customer satisfaction for new innovations, and help manage the product surveillance program. In order to meet business unit objectives, the Program Manager will be responsible for assuring the appropriate departments are pulled in as needed to deliver on expected results.

Requirements

• Bachelor's degree
• 5 yrs. relevant experience

Responsibilities

• Assure product/process/package designs and associated documentation comply with applicable Regulations for nutritional products and dietary supplements distributed in the U.S and Internationally.
• Collaborate with Regulatory Affairs to establish appropriate product filing strategies and provide necessary product documentation for submission.
• Participate in external Regulatory Agency inspections (FDA, Ministry of Health, etc) inquiries associated with product design, change control and complaints.
• Assure risks are identified, appropriately characterized and managed while meeting established project schedule and cost objectives.
• Establish and execute policies, procedures, processes and principles to provide robust product designs, assure appropriate evaluation during development and provide necessary change control.
• Collaborate with R&D to design development test plans for new Innovations.
• Establish and conduct appropriate start-up testing, reconcile results and release batches for commercial distribution.
• Effectively collaborate across all operational, technical and commercial functions at all levels of Division, company owned Plants and Third Party Manufacturer (TPM) Management to assure product performance & efficacy requirements are successfully translated into product/process design and specifications.
• Manage the impact of quality related design criteria on product and operational costs.
• Assure successful and cost-effective scale-up and technology transfer from R&D to commercial manufacture.
• Manage and execute commercial surveillance programs to monitor product performance over shelf life as required by Regulation.
• Assure that product performance is monitored via manufacturing non-conformances and complaints.
• Identify issues, investigate and implement corrective and preventative actions.
• Provide oversight of changes to plant work orders and TPM standard manufacturing plans, procedures and equipment/processes as they relate to product design, safety, performance, efficacy and testing.

Benefits

• 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, Medical Benefits start day 1.
• Vacation – 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 5 personal days + 10 paid holidays.
• 401(k) retirement savings with a generous company match of 5%.
• 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 stability of a company with a record of strong financial performance and history of being actively involved in local communities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees