Senior QA Manager

Location: Bangkok, Remote (Thailand)

Working hours: Monday Friday (8.00 17.00 hrs.)
Type of Hiring: Permanent

Role Summary

The Senior QA Manager APAC (excluding Japan) is responsible for ensuring all QA and compliance activities within the region meet applicable regulatory requirements. This role oversees QA Distribution across APAC (excluding JP) and provides leadership in quality systems, audits, and regulatory compliance for multiple legal entities. The position also ensures consistent implementation of global quality standards, including ISO 13485, across companys operations in Australia, China, India, and South Korea.

This leader works cross-functionally with global and regional teamsincluding Compliance, Regulatory, Manufacturing, Supply Chain, Clinical Affairs, Post-Market Surveillance, and Distributorsto strengthen quality processes, maintain inspection readiness, and drive continuous improvement.

Key Responsibilities

• Lead the regional QA team and oversee all quality processes supporting distribution, supply chain, vigilance, post-market surveillance, and regional operations.
• Manage budget, resources, hiring, training, and development of QA staff.
• Maintain and continuously improve the Quality Management System (QMS) in line with ISO 13485 and local regulatory requirements.
• Oversee internal and external audits; serve as lead auditor for companys sites, distributors, and suppliers.
• Design and manage the annual APAC audit program, ensuring proactive inspection readiness.
• Act as the main liaison for complaints, product quality issues, field actions, and vigilance reporting across the region.
• Ensure effective post-market surveillance and regulatory reporting, including adverse events and FSCA.
• Manage distributor compliance with Good Distribution Practice (GDP) and product-related regulations; provide training to staff and partners on QA requirements.
• Oversee QA oversight of 4PL vendor operations in Australia.
• Collaborate with global QA teams to harmonize SOPs, KPIs, and dashboards, support global quality projects and process improvements.
• Drive CAPA management and resolution of non-conformances.
• Represent QA in cross-functional communication with regulatory authorities, distributors, and internal stakeholders.

Requirements

Experience

• At least 7 years of QA management experience in a regulated environment (e.g., TGA, Medsafe, Thai FDA, Singapore HSA, Korean FDA).
• Strong knowledge of ISO 13485:2016 and international GDP.
• Proven track record in audit/inspection management; lead auditor certification preferred.

Skills

• Strong leadership, people management, and team development skills.
• Solid understanding of supply chain and distribution within medical devices.
• Excellent communication, presentation, and project management skills.
• Analytical and problem-solving capabilities, with the ability to influence and drive change.
• Proficiency in Microsoft Office, Excel, and process mapping tools.
• Fluent in English (spoken and written).

Education

• Bachelors degree in technical discipline (or equivalent background).

Travel

• Up to 20% travel, primarily within the region.

Readiness Thai Management Skills APAC Operations Compliance Product Quality Quality Management Oversight Distributors Management System Regulatory Requirements People Management Regulatory Compliance Hiring Supply Travel Excel Inspection Continuous Improvement Manufacturing Regulations Suppliers Education Design Project Management Microsoft Office English Leadership Training Communication Management