TPM Quality Projects Manager (Japanese Speaking)

Borr Drilling; Singapore; On-site; SGD 85,000 - 120,000; Full time

Job summary

A leading company in the nutrition sector seeks a TPM Quality Manager to oversee quality support for Third-Party Manufacturers in the Asia-Pacific region. The role involves building relationships, ensuring compliance with quality management systems, and driving continuous improvement initiatives while requiring fluency in Japanese and strong problem-solving skills.

Qualifications

• Minimum 5 years relevant experience, including 2 years in Japan Drug business.
• Fluent in Japanese and advanced in English.
• Strong understanding of PIC/S GMP.

Responsibilities

• Establish and maintain relationships with Third-Party Manufacturers.
• Provide training on quality expectations and support.
• Identify and resolve quality issues using problem-solving tools.

Skills

Problem Solving

Technical Writing

Communication

Attention to Detail

Continuous Improvement

Education

Bachelor’s degree in Quality, Science, Food, or related discipline

Job description

JOB DESCRIPTION

As TPM Quality Manager, you will report to the Regional Quality Manager within the International Third-Party Manufacturing Division of Abbott Nutrition. The role involves providing ongoing quality support for Business-as-Usual Third-Party Manufacturer relationships and initiating new business accounts as directed by the Regional Quality Manager to expand the Abbott Nutrition network through third-party solutions.

Major Responsibilities

1. Establish and maintain long-term relationships with Third-Party Manufacturers and material suppliers.
2. Provide training to the Third-Party Manufacturing team on Abbott expectations.
3. Provide QA and Technical Support to TPMs and AN Stakeholders.
4. Identify and resolve quality issues related to design, manufacturing, quality programs, and product start-ups at TPMs. Document issues and use problem-solving tools to investigate, determine root causes, and implement CAPA actions.
5. Ensure compliance and continuous improvement of audit and metric performance.
6. Maintain compliance with Quality Management Systems, including complaints, batch release, exception reports, CAPA, document control, training, and quality/performance metrics, especially for Japan Drug and Food business.
7. Drive cross-functional assessments for change control in accordance with regulation changes and supplier requests.
8. Write and revise SOPs, controlled forms, and related documents to align with current operations and best practices.
9. Report key metrics regularly and provide improvement recommendations based on data interpretation.
10. Negotiate Quality Agreements with Third-Party Manufacturers.
11. Participate in Cross-Functional Project Teams to coordinate all quality deliverables related to project milestones, including ingredient and packaging qualification, facility readiness, equipment validation, process validation, First Lot to Stock execution, and registration.
12. Act as the internal liaison between Division functions and Japan MAH to ensure compliance with nutritional quality systems and Japan Pharma requirements, reflecting these accurately within the quality system and performing holistic change impact assessments.
13. Support AN and TPM to interpret and implement Japan Pharma GMP requirements related to the product portfolio.

Supervisory/Management Responsibilities

The position may have direct reports and will require establishing close working relationships with international and external stakeholders, both locally within Japan and internationally.

Requirements

• Bachelor’s degree in Quality, Science, Food, or related discipline.
• Minimum of 5 years relevant experience, including at least 2 in Japan Drug business.
• Excellent understanding of PIC/S GMP and experience in Quality Operations is advantageous.
• Fluent in Japanese (written and spoken) and advanced in English.
• Strong problem-solving and technical writing skills, with experience in problem-solving tools.
• Excellent communication and presentation skills.
• High attention to detail and accuracy.
• Enthusiastic, energetic, and collaborative.
• Innovative mindset with a focus on continuous improvement.
• Responsible for routine activities related to two or more TPM accounts in the region.