QA Specialist, Commercial Quality Thailand

About the Company

Johnson & Johnson is a global leader in healthcare innovation, working across Innovative Medicine and MedTech to prevent, treat, and cure complex diseases. We provide medical devices and diagnostics products that are scientifically sound and of high quality to improve patient outcomes and quality of life.

About the Role

The Commercial Quality department provides quality oversight and support to local operating companies across strategy, quality system oversight, compliance reporting, product lifecycle management, and distribution. This position is responsible for end-to-end support on appointed MedTech processes including repack/relabel, NC/CAPA, change control, warehouse operations, and complaint handling. The role supports quality systems implementation and maintenance for Thailand and LCM countries (Laos, Cambodia, Myanmar), including oversight of 3PLs and distribution centers to meet regulatory, customer, and Johnson & Johnson standards.

This role reports to the Senior Commercial Quality Manager, SEA & India Cluster EP.

Key Responsibilities

Site Quality Management System Activities:

• Report adverse events and product quality issues to health authorities as required by local regulation; ensure robust processes for timely reporting and closure
• Lead site change control management; ensure processes are followed with proper impact assessment and monitoring; manage records in a timely manner
• Lead end-to-end complaint management; prepare and sign customer resolution letters; monitor trends and metrics; initiate improvement actions
• Support and ensure site compliance to document lifecycle management
• Provide quality support for repack/relabel operations including updating quality agreements and issuing redressing instructions; ensure compliance to internal procedures and local regulations
• Lead NC/CAPA management; ensure proper investigation, root cause analysis, and corrective/preventive actions; manage records and monitor metrics
• Support and ensure compliance to GxP training plans for quality system elements; responsible for metrics, communications, reports, and non-conformance
• Support business needs and leadership development as assigned by line manager

3PL and Distributor Quality Oversight:

• Execute and ensure compliance of quality management systems applicable to 3PL and distributors per J&J standards and local regulations
• Oversee storage, temperature controls, traceability, repack/relabels, loaner set management, and NC/CAPAs

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, or equivalent from a reputable university, preferably with excellent academic background
• At least 1 year professional experience in Quality Assurance, Business Quality, or related functions
• Experience with quality audits
• Exposure to quality standards such as ISO, GMP, GDP, and regulatory requirements
• Experience with regional communication
• Excellent interpersonal, leadership, and quality management skills
• Strong communication, coordination, and interpersonal abilities
• Good command of written and spoken English and Thai
• Computer literacy

Preferred Skills

• Audit Management
• Coaching
• Compliance Management
• Continuous Improvement
• Data Analysis
• Detail-Oriented
• Internal Controls
• Issue Escalation
• Problem Solving
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment