Johnson & Johnson Careers

Senior Business Quality Executive

Bangkok, Bangkok
Quality Control

Job Description

Requisition ID: 1805650284W

Senior Business Quality Executive
Overall Responsibility
Provide an overview of the job by summarizing in one or two sentences, the main purposes of this job and what it contributes to the overall business of the organization.
The position provides an overview of quality compliance of Thailand Sale and Marketing Company. Engaged with Sale and Marketing team to ensure Thailand marketed product are launched on schedule and in compliance with local regulatory, J&J requirements, GMP, Safety Health, Environmental and cooperate quality standard from product importation through to commercialization and distribution.
Principal Responsibilities
Listing of the job’s major responsibilities preferably in order of importance. Statements should identify the most predominant and significant duties and convey a measure of frequency and occurrence.
1)            Manage and maintain the Change Control/Document Management Systems and processes, including the following:
•             Maintain and manage the associated work flows for new/revised documents and changes.
•             Manage the requests for, issuance and subsequent archival of documents and changes
•             Manage access rights for the system to access document system
•             Assess the criticality of changes and track the closure of tasks associated with the change.
2)            Manage and maintain the Internal Audit system, including the following:
•             Own and /or oversee the day-to-day running of the Internal Audit systems
•             Plan / participate in the Internal Audits for the site
•             Write up finding reports for the Internal Audits and determine the actions required
•             Raise /Follow up and Closure of CAPAs generated from Internal Audits
3)            Manage and maintain the External Audit/Third party / Regulatory Inspection system including the following
•      Provide pre audit campaign training to the site
•             Raise /Follow up and Closure of CAPAs generated from Audit / Regulatory Inspection. Coordinate with Quality Manager on all post inspection activities and support post-audit execution of corrective action and preventive action
•             Lead, plan and implement audit program of Third Party/service providers to ensure compliance.
•             Coordinate with Supply chain, Third Party/service providers on scheduled audits and CAPA actions to ensure timely closure.
4)            Manage and maintain the NCR and CAPA tracking system including the following:
•             Own and /or oversee the day-to-day running of the CAPA systems
•             Providing metrics to the country council on a regular basis
•             Providing site training on the CAPA system for new hires and for changes to the system
•             Manage access rights for the CAPA database system
•             Undertake troubleshooting and solutions, root cause analysis to quality issues through statistical analysis and process excellence tools
5)            Manage and maintain the Compliant Vigilance and Field Action tracking system including the following:
•             Own and /or oversee the day-to-day running of the Complaint Management System
•             Providing metrics to the country council on a regular basis
•             Providing site training on the Complaint Vigilance for new hires & employees.
•             Participate in coordination of field actions, liaising with regulators, sales and marketing, field sales engineers, customer service and warehouse personnel as appropriate, to ensure all activities are executed accordingly and within the stipulated timeframes, under the guidance of Professional Affairs Manager.
6)            Support Management Review
•             Prepare metrics (e.g. external and internal audit performance, complaint and adverse event trending, CAPA status, NCR closure) for Management Review and track all after review actions to closure. Recommend initiatives for compliance enforcement.
7)            Projects and Risk Management
•             Represent J&J QA on 3P-related activities and projects inclusive of managing Quality Agreements, vendor/supplier/distribution qualification. Interface with external bodies and certification bodies on quality audits.
•             Consolidate all risks identified and assess the risk criticality. Compile, communicate and escalate high risks to management for action plan in accordance to quality risk management procedures.
8)            General
•             Author and/or approve procedures, work instructions
•             Lead and /or participate in executing the implementation plans
•             Prepare training materials, organize and conduct quality systems training as required. Train people in process improvement methodologies, techniques, tools, root cause analysis, quality language etc.  to improve processes and improve business results
•             Enforce the requirements of the quality systems ensuring simplicity, standardization and education across the functions, requirements are effectively established and executed throughout the organization in accordance with Good Distribution Practices, Medical Device and Diagnostics standards/ requirements, J&J policies & local regulations.
•             Any other duties or project as assigned by Head of One J&J Business Quality Thailand

  • Bachelor’s degree or higher in Science
    Professional Experience:        
  • Experience in QC or related fields.
  • Extensive on quality auditing experience in a consumer product, pharmaceutical and medical device would be advantage.
  • QC exposure to quality standard eg.ISO, GMP, GDP, RA requirements will be desirable.
    Knowledge & Skills:
  • Quality Auditing and Quality System.
  • Strong communication skill with leadership abilities. Good coordination and interpersonal skills.
  • Good command of written and spoken Thai and English together with computer literacy.

Primary Location
Johnson & Johnson (Thailand) Ltd. (8585)
Job Function
Quality Control
Requisition ID