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. This role reports solid line to Cluster Commercial Quality Head for Thailand, Vietnam, and Indonesia in Vietnam. This role is responsible for the site management and execution of Quality Systems establishment, 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.

Essential duties and responsibilities:

Site quality management system activities:

1. Acquisition and divestiture:

• Provides quality support for acquisition and divestiture activities, including change control.

2. 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.

3. Audit Readiness, including Inspection management:

• Ensures compliance and audit-readiness of site to J&J Quality Policy Standards and applicable local regulatory requirements.

• Lead as site SME for inspection management by coordinating activities related to pre- and post- audit including providing briefing and guidance to all cross functional team, managing audit arrangement and lead in audit response to auditor.

4. 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.

5. 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.

6. Document control

• Support and ensure site compliance to document lifecycle management.

7. 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.

8. 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.

9. New Product Introduction and Product Discontinuation

• To provide Quality support during new product launch and establish any new quality processes to support commercial launch if applicable.

10. Escalation and Field actions

• Oversee the management of Escalations, Field Action, Mock Field Action and Stop shipment applicable to the site.

11. Product Release and Product Returns

• Supports activities related to product inspection and release, temperature excursions and trade returns according to product specifications and internal procedures.

12. Purchasing Control, including POLO

• Support activities related to purchasing controls. Ensures suppliers/POLO are appropriately qualified, monitored and in compliance to up-to-date Quality Agreements, where applicable.

13. QSMR and metrics reporting

• Coordinates key quality metrics reporting. This includes Non-conformance, CAPA, Complaints, Change Control, Audit Actions tracking and monitoring as per timelines.

14. Quality Manual

• Responsible to establish and maintain site's Quality Manual

15. Records retention

• Provide guidance to LOCs on record retention process in collaboration with records coordinator.

16. Training Management

• Support and ensure site compliance to GxP training plan for quality system elements covered by the site's quality manual. This role is also responsible for the metrics, communications, reports and non-conformance related to these areas.

3PL and Distributor quality oversight

1. 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: product release and returns, handling of storage, temperature controls, traceability, repack relabels, loaner set management, and NC/CAPAs. 2. This role is also responsible for purchasing control activities related to the distributor such as qualification, audits, and monitoring of distributor quality KPIs.

Qualifications

Job Requirement

• Bachelor's degree or equivalent in Science, Pharmacy or related discipline

• Minimum 3 years of experience in the related field, preferred in medical device or pharmaceutical industry.

• Experience in QC or related fields

• QC exposure to quality standard e.g. ISO, GMP, GDP, RA requirements will be desirable

• Have knowledge of GMP and/or equivalent Quality Assurance Systems

• Capability to communicate and good coordination and interpersonal skills

• Good command of written and spoken Thai and English together with computer literacy