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.  Abbott Nutrition for Health Care Professionals | Abbott

Position: Quality Projects Manager TPM - Japan

Primary Function / Goals / Objectives

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 internal AN  and external stakeholders both locally within Japan and Internationally.

Education Required

Bachelor’s degree in pharmacy.A Bachelor’s degree in a Quality, Science, or Food related discipline will be considered.

Knowledge

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

Accountability / Scope

Responsible for all routine activities related to two or more specific TPMs accounts in region

The position impacts directly on product quality and thus the financial and regulatory exposure of decisions could be significant

The position requires Quality decision making as primary point of Quality in region

Activities broadly defined by agreed goals. Supervision is received through meetings and one on one meeting with the Regional Quality Manager.  Periodic goal reviews, annual performance and career development reviews will also occur