Senior Project Leader TPM Quality Assurance - Columbus, OH

Abbott • Columbus, OH

2d • Onsite

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: Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance 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 your family, be your true self, and live a full life. You’ll 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 Opportunity Our location in Columbus OH currently has an opportunity for a Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance. This individual will serve as the primary account manager for all things quality for multiple suppliers that manufacture nutritional products on behalf of Abbott Nutrition. The primary duties within this role include: (1) event management and responsibilities for the Abbott CAPA system, (2) project management as it relates to new product launches, trials, rebranding, etc., and (3) compliance within the Abbott quality system as it relates to our supplier base. Within this role you will serve as the representative of Abbott to the supplier for numerous technical departments while coordinating activity with the supplier on behalf of regulatory, R&D, procurement, package engineering, and many more internal stakeholders. Conversely, the individual in this role must also be responsible for accurately serving as a representative of the supplier in numerous meetings and exchanges internally within Abbott. This individual must work closely with the Compliance Manager to ensure compliance with Federal Regulations, International Standards/Directives, or other applicable governing bodies as they relate to the elements of the Quality Management System. This individual must also serve as Subject Matter Expert (SME) for the CAPA processes, and liaison into Division Quality Systems for Abtraq /CAPA and AMR Metrics. Additionally, they must work closely with cross-functional personnel to lead or support failure investigations and collaborate with other plant functional areas and Division Quality Systems to maintain adequate and timely documentation updates within the systems. The role also must write and/or review specifications, engineering studies, validation packages, change requests, etc. to ensure product quality is maintained, and use quality tools to improve and assure quality.

Requirements

• Bachelor's degree, preferably in a science, engineering or life/physical sciences
• At least 5 years in a QA Role/Compliance/Quality Systems or closely related position in a federally regulated industry

Nice To Haves

• Preferred experience within a Global, multi-cultural organization.
• Thorough knowledge of manufacturing processes and quality assurance principles; with the ability to operate to internal and federal regulations.
• Results-driven with ability to successfully interact and communicate with all organizational levels internally and externally (e.g. suppliers or external regulatory bodies); Demonstrated ability to manage several activities / projects at once, organize / prioritize work.

Responsibilities

• Implement the Quality Record (QR) / CAPA system to assure timely identification of root cause, and effective CAPA plans.
• Assist with, initiate, investigate, and/or plan correction activities, as required, when nonconformances are identified and lead or support the resolution and closure.
• Support and influence suppliers to drive to true root cause and implement effective corrective actions.
• Track and trend established QA metrics (KPI and CAPA).
• Communicate monthly and /or quarterly data, as required, to the TPM, the Division and Corporate Levels.
• Identify new and / or modify and enhance existing sources of quality data for Continuous Improvement meetings.
• Facilitate Quarterly Business Reviews (QBR) meetings to report supplier quality performance.
• Identify opportunities for improvements within CAPA system.
• Support and ensure technical readiness by the supplier in advance of new product launches, trials, etc.
• Maintain relevant documentation (ie. QA policies, procedures, specifications, and acceptance programs) and assure these documents are current and compliant to division and corporate level policies and procedures as well as external governing bodies.
• Assess gaps (where they exist) between plant and corporate and division level documents as well as in training profiles / curriculums and develop action plans to correct.

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