Plant General Manager (Indonesia Base)

Huge Dental; Tangerang; On-site; IDR 600,000,000 - 1,200,000,000; Full time

Job summary

Huge Dental in Tangerang, Indonesia, is seeking a senior manufacturing leader to oversee factory establishment, licensing, and long-term capacity planning. You will coordinate with government authorities, define production targets, and build strategic plans for growth while ensuring regulatory alignment.

The role requires ISO 13485, CPAKB, CDAKB familiarity, strong leadership, and fluent Indonesian and English.

Qualifications

• Bachelor’s degree or higher in a relevant field.
• 5+ years’ experience in manufacturing management, with 3+ years in a senior leadership role.
• Experience in medical device or regulated manufacturing sectors preferred.
• Fluent in Bahasa Indonesia and English; Mandarin is a plus.

Responsibilities

• Oversee factory establishment activities, including location assessment and licensing.
• Lead strategic production plans covering capacity, workforce, budget, and growth.
• Manage production expenses and drive cost efficiency while maintaining quality.
• Ensure ISO 13485, CPAKB, CDAKB compliance and internal standards.
• Oversee regulatory registration activities with Ministry of Health, FDA, EU MDR, and other authorities.
• Develop and enforce management systems, evaluation criteria, and policy adherence.
• Ensure quality management processes are defined, implemented, and maintained.

Skills

Leadership

Regulatory compliance

Stakeholder management

Quality systems

Communication

Bilingual English/Indonesian

Problem solving

Education

Bachelor’s degree or higher in Engineering/Manufacturing/Business

Job description

• Factory Establishment & Strategic Planning: Oversee all preparatory activities for the Indonesian factory prior to production, including location assessment, project licensing, and coordination with relevant government bodies. Build and maintain strong relationships with government authorities to ensure compliance, smooth approvals, and long-term operational stability. Lead the creation of strategic production and operational plans covering capacity, workforce allocation, budget, and long-term growth objectives.
• Financial & Cost Management: Manage and monitor production expenses, including raw materials, manpower, and utilities. Implement efficiency improvements to control costs while sustaining product quality and operational performance.
• Production Oversight: Develop and execute annual production targets and operational strategies to ensure timely delivery. Monitor shop-floor operations through regular inspections, provide guidance, and manage production workflows to maintain high efficiency and meet quality benchmarks.
• Quality Assurance & Compliance: Ensure products meet ISO 13485, CPAKB, CDAKB, and internal quality requirements. Conduct periodic audits, address non-conformities, and maintain alignment with both company and regulatory standards.
• Supply Chain & Procurement Management: Select and evaluate reliable suppliers, establish long-term partnerships, and secure timely raw material supply. Oversee inventory management and optimize logistics processes to reduce lead times and costs.
• Regulatory Registration & Certification: Oversee preparation and submission of technical documentation to meet Indonesian Ministry of Health, FDA, EU MDR, and other applicable regulatory requirements. Ensure timely completion of product registration and certification.
• Systems & Policy Implementation: Develop and enhance management systems for the Indonesian factory. Establish employee evaluation criteria, reward systems, and enforce policies to ensure consistent application across the organization.
• Management Representative Responsibilities: - Ensure all processes required for the quality management system are defined, implemented, and maintained.

Requirements / Qualifications:

• Bachelor’s degree or higher in Engineering, Manufacturing, Business Administration, or related fields.
• Minimum over 5 years’ experience in manufacturing management, with at least 3 years in a senior leadership position.
• Proven experience in managing large-scale production facilities, preferably in the medical device or regulated manufacturing sector.
• Strong understanding of ISO 13485, CPAKB, CDAKB, TKDN, and regulatory compliance requirements.
• Demonstrated ability to build and maintain positive relationships with government agencies and regulatory authorities.
• Excellent leadership, communication, and problem-solving skills.
• Fluent in Bahasa Indonesia and English is a must; Mandarin proficiency is an advantage.