Global QA Director — Multi-Site & Regulatory Excellence

Agensi Pekerjaan Executive Recruiters; Kuala Lumpur; On-site; MYR 320,000 - 600,000; Full time

Job summary

Agensi Pekerjaan Executive Recruiters is seeking a General Manager of QA to lead quality strategy across all manufacturing sites in Kuala Lumpur. The role partners with senior leadership to ensure compliance with global regulatory requirements and maintains a robust QMS to drive continuous improvement.

The candidate should have 15+ years in manufacturing with 8+ in management, preferably in medical devices or regulated industries, and strong CAPA, audit, and project management skills.

Qualifications

• Minimum 15 years of manufacturing experience with at least 8 years in managerial roles.
• Experience in medical devices or other regulated industries is preferred.
• Demonstrated leadership in QMS, regulatory compliance, and customer-facing quality functions.

Responsibilities

• Lead QA strategy across all plants and central functions.
• Develop and implement long-term quality plans aligned with regulatory requirements.
• Oversee QMS maintenance, CAPA, audits, and supplier quality management.
• Prepare for regulatory inspections and major customer audits.
• Manage QA budgets, resources, and headcount to support operations.
• Drive cross-functional root cause analysis and systemic quality improvements.

Skills

GMP knowledge

QMS knowledge

CAPA

Root cause analysis

Regulatory compliance

Lean & process improvement

Leadership

Communication

Project management

Education

Bachelor’s or Master’s Degree in Engineering/Science or related field

Job description

Agensi Pekerjaan Executive Recruiters is seeking a General Manager of QA to lead quality strategy across all manufacturing sites in Kuala Lumpur. The role partners with senior leadership to ensure compliance with global regulatory requirements and maintains a robust QMS to drive continuous improvement.

The candidate should have 15+ years in manufacturing with 8+ in management, preferably in medical devices or regulated industries, and strong CAPA, audit, and project management skills.