Quality & Regulatory Assistant Manager

Job Summary

The purpose of this position is: to ensure all Suntory products comply to

Food Safety & Quality requirements, MQR/GMP/GDP, Product Specifications and manufacturing procedures.
International and Country Regulations.

Job Responsibilities

Quality Responsibilities:

• Manage Quality Management System, MQR, Blue Book implementation, and Protect the Castle program at Co-manufacturers.
• Support annual audits, manage CAPAs, and verify their effectiveness.
• Conduct Gemba and site inspections as needed at Co-manufacturers.
• Manage external inspections, complaints, deviations, recalls, and product tampering.
• Provide QA support on process validation at Co-manufacturers.
• Manage yearly Water Activity Exercises and collaborate with SBF QA.
• Analyze quality failures and recommend corrective actions.
• Ensure products meet Suntory specifications before market release.
• Oversee Change Control processes at Co-manufacturers.
• Coordinate with stakeholders on new projects and product innovations.
• Support quality improvement, stability, and internal change control programs.
• Manage supplier qualifications and audits.

Regulatory Responsibilities:

• Review regulatory documents for compliance.
• Provide regulatory guidance for product innovation and development.
• Ensure products comply with company policies and local regulations.
• Manage halal certifications and regulatory compliance applications.
• Oversee packaging, artwork, and labeling approvals.
• Maintain regulatory databases and records.
• Build strong relationships with co-manufacturers and regulatory bodies.

Your Team

Line manager: Quality Compliance Manager
Role type: Sole contributor
Total team size: 6

Skills and Experience

• Tertiary degree in Bioscience, Food Science, or a related discipline.
• Minimum 5 years of experience in the FMCG industry within a GMP-regulated environment, with substantial experience in GMP auditing.
• Experience in Quality Management Systems, audits, validation, complaint handling, change control management, production, and technical operations.
• Strong knowledge of food regulations and experience working with regulatory bodies.
• Proficiency in English, Bahasa Malaysia, and Chinese.
• Experience in managing quality for third parties (co-manufacturing) and preparing them for regulatory inspections.
• QMS knowledge and experience in QMS implementation.
• Strong interpersonal, motivational, and communication skills to effectively interact with customers and stakeholders at all levels.
• High degree of initiative and self-motivation.

Education