Tpm Quality Projects Manager (Japanese Speaking)

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 suppliers
• Provide necessary training to the Third-Party Manufacturing team on Abbott expectations
• Provide QA and Technical Support to TPMs and AN Stakeholders
• Identify 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 implemented
• Ensure compliance and continuous improvement of audit and metric performance
• Ensure 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 business
• Drive cross functional assessment for change control in accordance with regulation changes, requests from suppliers or Third-Party manufacturers
• Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations
• Collate and report up key metrics on a weekly / monthly / quarterly / annual basis and provide recommendations for improvement based on interpretation of data
• Negotiate with Third Party Manufacturer on Quality Agreements
• Participation 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 registration
• Act 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 arises
• Support 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.

Requirements

• A bachelor’s degree in a Quality, Science, or Food related discipline will be considered
• A minimum of 5 years relevant work experience, at least 2 of which is in the Japan Drug business
• Excellent understanding of PIC/S GMP with previous experience in a Quality Operations role a distinct advantage
• Fluent in written and spoken Japanese
• Advanced level written and spoken English
• Excellent problem-solving and technical writing skills with experience in the use of problem-solving tools as challenges may be unique or previously unmet
• Excellent communication and presentation skills are essential for this role
• Excellent attention to detail and accuracy
• Enthusiastic and energetic with the ability to collaborate
• Innovative and Continuous Improvement mindset
• Responsible for all routine activities related to two or more specific TPMs accounts in region.