Senior Project Leader (TPM) Quality - Nutrition - 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 109,000 colleagues serve people in more than 160 countries.

Senior Project Leader (TPM) Quality

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 Senior Project Leader (TPM - Third Party Manufacturing)

The Senior Project Leader (TPM) will serve as the primary account manager for all things quality across multiple suppliers that manufacture finished 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 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.

WHAT YOU'LL DO
  • 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.


Accountability / Scope/Budget:
  • This position reports directly to the TPM Quality Manager for the Americas food manufacturers, 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 AN division inventories and the ability to service customer demands


EDUCATION AND EXPERIENCE, YOU'LL BRING
  • Bachelor's degree, preferably in a science, engineering or life/physical sciences.
  • Food industry a plus, but not required.


Preferred:
  • 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, organize / prioritize work.


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

    Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com

    Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

    Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.


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