Job Information
Abbott TPM QA Project Manager in Tokyo, 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 nutritional 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 from product complaints or other sources from the quality system ensuring root cause is determined and appropriate CAPA actions implemented
Ensure compliance and continuous improvement of audit and metric performance
Responsible for overall quality and safety of products manufactured at the TPM(s)
Ensuring compliance to Quality Management Systems including complaints, batch release, exception reports, CAPA, document control, training, quality/performance metrics etc in relation to Japan Drug or 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 / 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 readiness and execution and registration
Supervisory/Management Responsibilities:
The position has direct reports.
The position will require establishing close working relationships with both internal TPM QA and Operations Managers and external TPM QA and Operations Mangers.
Education Required:
Bachelor’s Degree in a Quality, Pharmacy, Science, or Food related discipline.
Knowledge:
A minimum of 5 years relevant work experience at least 2 of which is in the Japan Drug or Food business
Demonstrated leadership skills/competencies with track record of success.
Excellent understanding of GMP with previous experience in a Quality Operations role a distinct advantage
Excellent problem-solving and technical writing skills with experience in the use of problem-solving tools as challenges may be unique or previously unmet
Fluent in written and spoken Japanese
Advanced level written and spoken English
Excellent communication and presentation skills are essential for this role
Excellent attention to detail and accuracy
Enthusiastic and energetic with the ability to collaborate and deliver measurable improvements
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 contact 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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com