QA Specialist, Commercial Quality Thailand

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

About the Role

Overall Purpose Of Job: Johnson & Johnson (J&J) MedTech provides medical devices and diagnostics products and ensures products and services are scientifically sound and of high quality. The Commercial Quality department provides quality oversight and support in strategy and planning, quality system oversight, compliance reporting, portfolio and product lifecycle management, product supply, and distribution. This role is responsible for end-to-end support of appointed MedTech processes (e.g., repack/relabel, NC/CAPA, Change Control, Warehouse (DC/3PL/Distributor), complaint handling) and supports implementation and maintenance of Quality Systems for Thailand and LCM countries (Laos, Cambodia, Myanmar), including oversight of 3PLs and Distribution Centres to meet regulatory and customer requirements and J&J policies and standards.

Reports solid line to Senior Commercial Quality Manager, SEA & India Cluster EP. Location: Bangkok. Onsite. Full-time.

Responsibilities

• Adverse event and/or Health Authority reporting: ensure adverse events/product quality issues are reported to health authority when required and that processes enable timely reporting and closure
• Lead site Change Control management: ensure process adherence, timely records, proper impact assessment, monitoring and metrics with actions for improvement
• Lead end-to-end complaints management: manage complaint handling, prepare and sign customer resolution letters when requested, monitor trends and metrics and initiate improvements
• Document control: support and ensure site compliance to document lifecycle management
• Labeling and packaging: provide quality support for repack/relabel operations (update quality agreements, issue redressing instructions) and monitor related metrics
• NC/CAPA management: lead NC/CAPA process, ensure investigations, root cause analysis, corrective and preventive actions, and metric monitoring
• Training management: support and ensure compliance to GxP training plan for quality system elements covered by the quality manual
• 3PL and Distributor quality oversight: execute and ensure compliance of QMS elements for 3PLs and Distributors including storage, temperature controls, traceability, repack/relabel, loaner set management, and NC/CAPAs
• Prepare metrics, communications and reports and manage non-conformance related to these areas
• Perform other duties as assigned to support the business and develop leadership skills

Qualifications

• At least BSc. in Science, Engineering, Pharmacy or equivalent from a reputable university; preferably with strong academic background
• At least 1 year professional experience in Quality Assurance, Business Quality or related functions
• Experience of quality audit
• Exposure to quality standards (e.g., ISO, GMP, GDP) and regulatory requirements desirable
• Experience of regional communication and good coordination/interpersonal skills
• Good command of written and spoken English and Thai; computer literacy

Skills

• Audit Management, Compliance Management, Quality Management Systems (QMS), NC/CAPA, Change Control, Complaint handling, data analysis and attention to detail