As TPM Quality Manager, you will be reporting to the Regional Quality Manager within the International Third-Party Manufacturing Division of Abbott Nutrition.  The role will have responsibility for the on-going Quality support of Business-as-Usual Third-Party Manufacturer relationships and initiation of new business accounts as directed by the Regional Quality Manager to augment the Abbott Nutrition network through the provision of third party solutions

Major Responsibilities

Establish and maintain robust long-term working relationships with new and existing Third-Party Manufacturers and material suppliersProvide necessary training to the Third-Party Manufacturing team on Abbott expectationsProvide QA and Technical Support to TPMs and AN StakeholdersIdentify and resolve quality issues related to design, manufacturing, quality programs and product start ups at TPMs.  Document Quality Issues and use problem solving tools to conduct and support investigations as they arise ensuring root cause is determined and appropriate CAPA actions implementedEnsure compliance and continuous improvement of audit and metric performanceEnsure compliance to Quality Management Systems including complaints, batch release, exception reports, CAPA, document control, training, quality/performance metrics etc in relation to Japan Drug and Food businessDrive cross functional assessment for change control in accordance with regulation changes, requests from suppliers or Third-Party manufacturersWrite and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operationsCollate and report up key metrics on a weekly / monthly / quarterly / annual basis and provide recommendations for improvement based on interpretation of dataNegotiate with Third Party Manufacturer on Quality AgreementsParticipation on Cross Functional Project Teams to co-ordinate all Quality deliverables associated with project milestones to include but not limited to ingredient and packaging qualification, facility readiness, equipment and utility qualification, process and test method validation, First Lot to Stock execution and registrationAct as internal liaison between Division functions and Japan MAH to ensure both core nutritional quality system and Japan Pharma requirements are met.  Ensure requirements for same are accurately reflected with in the quality system and change impact assessment is performed holistically as change arisesSupport AN and TPM to interpret and implement Japan Pharma GMP requirements as they relate to the AN product portfolio

                       

 Supervisory/Management Responsibilities

The position may have direct reports.

The position will require establishing close working relationships with both international and external stakeholders both locally within Japan and Internationally.

RequirementsA bachelor’s degree in a Quality, Science, or Food related discipline will be consideredA minimum of 5 years relevant work experience, at least 2 of which is in the Japan Drug businessExcellent understanding of PIC/S GMP with previous experience in a Quality Operations role a distinct advantageFluent in written and spoken JapaneseAdvanced level written and spoken EnglishExcellent problem-solving and technical writing skills with experience in the use of problem-solving tools as challenges may be unique or previously unmetExcellent communication and presentation skills are essential for this roleExcellent attention to detail and accuracyEnthusiastic and energetic with the ability to collaborateInnovative and Continuous Improvement mindsetResponsible for all routine activities related to two or more specific TPMs accounts in region.