Commercial Quality Specialist , Surgery (MedTech)

Job Description

Overall purpose of job:

Johnson & Johnson (J&J) MedTech is a provider of medical devices and diagnostics products to the market. It ensures that its products and services are scientifically sound and of high quality to help heal, cure disease, and improve the quality of life of patients and consumers. The Johnson & Johnson Commercial Quality department provides quality oversight and support to the local operating companies in the areas of strategy and planning, quality system oversight, compliance reporting, portfolio and product lifecycle management, product supply, and distribution.

Responsible for E2E support on appointed Medtech process e.g., repack/relabel, NC/CAPA, Change Control, Warehouse (DC/3PL/Distributor plus), complaint handling and support commercial quality team in execution of Quality Systems implementation and maintenance for Thailand and LCM countries (Laos, Cambodia, and Myanmar) including overseeing of 3PLs and Distribution Centers in order to meet the applicable regulatory and customer requirements and Johnson & Johnson policies and standards

This role reports solid line to the Associate Commercial Quality Manager, Johnson & Johnson MedTech Thailand.

Key responsibilities:

Site quality management system activities:

• Adverse event and/or Health Authority reporting
  Responsible to report adverse events/product quality issues are reported to the health authority in the site if required by local regulation, and ensures robust processes are in place for timely reporting and closure
• Change Control
  Lead for site’s change control management. Responsible to ensure process is followed and records are managed in a timely manner with proper impact assessment, monitoring are taken. Monitors related metrics and initiates actions for improvement.
• Complaints management
  Lead the end-to-end complaint management for the site. Responsible to prepare and sign customer resolution letters when requested by complainant. Monitors trends, related metrics and initiates actions for improvement.
• Document control
  Support and ensure site compliance to document lifecycle management.
• Labeling and packaging
  Provides Quality support (such as updating quality agreements, issuing redressing instructions) in repack/relabel operation to ensure compliance to internal procedures and local regulations. Monitors related metrics and initiates actions for improvement.
• NC CAPA Management
  Lead for site’s NC/CAPA management. Responsible to ensure process is followed and records are managed in a timely manner with proper investigation, root cause analysis and corrective and preventive action taken. Monitors related metrics and initiates actions for improvement.
• Training Management
  Support and ensure compliance to GxP training plan for quality system elements covered by the quality manual.

This role is also responsible for the metrics, communications, reports and non-conformance related to these areas

• Other duties and projects assigned by line manager to support the business and help to develop leadership skills

3PL and Distributor quality oversight

This role is responsible for the execution and compliance of Quality Management Systems elements applicable to the 3PL and Distributor as required per J&J standards and applicable local regulatory regulation, including: handling of storage, temperature controls, traceability, repack relabels, loaner set management, and NC/CAPAs.

Required Qualification and Core Competencies for the role:

Education:

• At least BSc. in Science or Engineer or Pharmacy or equivalent from a reputable university preferably with excellence academic background

Professional Experience:

• At least 3 years professional experience or leading in the field of Quality Assurance, Business Quality in healthcare business or related business and functions
• Experience of quality audit, improvement process
• Excellent interpersonal, leadership and quality management skill
• Exposure to quality standard e.g. ISO13485, GMP, GDPMD, RA requirements will be desirable
• Experience of exposure to Regional communication
• Capability to communicate and good coordination and interpersonal skill
• Good command of written and spoken Thai and English language together with computer literacy

Job location:

Johnson and Johnson MedTech (Thailand) Co.,Ltd.
134/1 Soi Chalongkrung 31, Khwaeng Lumplatew, Khet Latkrabang, Bangkok. 10520

Required Skills:

Preferred Skills:

• Business Behavior
• Compliance Management
• Continuous Improvement
• Data Analysis
• Data Compilation
• Detail-Oriented
• Execution Focus
• Goal Attainment
• Internal Controls
• Issue Escalation
• Process Oriented
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Regulatory Environment
• Report Writing