Senior Project Leader TPM (Third Party Manufacturing) Quality Assurance - Columbus, OH

Abbott • Columbus, OH

9h • Onsite

About The Position

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. 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 get the nutrients they need to live their healthiest life.

This individual will serve as the primary account manager for all things quality across multiple suppliers that co-pack nutritional products and manufacture pediatric accessories 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 Plant 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.
• Food industry a plus, but not required.
• Preferred experience within a Global, multi-cultural organization.
• Preferred experience in Quality Assurance or supplier quality management: at least 5 years in a QA Role / Compliance / Quality Systems or closely related position.
• Experience within a federally regulated industry is a plus, but not required.
• 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 with a strong sense of urgency, effectively prioritize work, and respond to time-sensitive business needs.

Responsibilities

• Monitor the Exception Report (ER) / 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 Division and Corporate Levels.
• Identify new and / or modify and enhance existing sources of quality data for Continuous Improvement meetings.
• Facilitate Material Review Board (MRB) meetings to report status updates for open exception reports and allocate appropriate resources to meet target closure deadlines.
• 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.
• Simplify, consolidate, and streamline procedures and forms used within the plant.
• Lead negotiations and execution of Quality Agreements and Standard Manufacturing Plans (SMPs) with suppliers, ensuring compliance with Abbott standards and regulatory Accountability requirements.
• This position reports to the TPM Quality Manager for the Americas copacking and pediatric accessories, and is challenged to effectively provide direction, support, and leadership in ensuring the alignment of site level documents with division and corporate level policies and procedures and in working with the Compliance Manager to ensure compliance with Federal Regulations, International Standards/Directives, or other applicable governing bodies.
• In maintaining an effective Quality Management System and overseeing compliance to the overall operation, this position assists the Compliance Manager in providing oversight and ensuring that regulatory requirements are correctly interpreted and addressed.
• Failure to do so can result in regulatory vulnerability and regulatory action.
• In addition to the FDA or any other regulatory agency's impact, this position's actions when dealing with exception reporting, failure investigations, and the development of planned corrections and corrective actions can result in product recall or liability suits that may result in adverse publicity, branding and a reduction of sales on a long-term basis.
• Also, the inability to comply or to bridge a gap in the Quality System due to a compliance issue can greatly impact Abbott Nutrition (AN) division inventories and the ability to service customer demands.

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: Senior