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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Seoul, Korea, Republic of
Job Description:
The positions responsibility oversights Quality & Compliance and Quality Systems execution in compliance with local regulatory requirements and J&J policies and standards. North Asia (HK, TW and KR)
[Key Responsibilities]
- Quality Management System (QMS) Compliance
- Ensure compliance of the Quality Management System against company Quality Policies and local regulatory requirements
- Develop and maintain local quality processes as required
- Monitor compliance and drive continuous improvement initiatives
- undefined
- CAPA / Change Control / Audit Management
- Support and drive timely management of Non-conformance, CAPA, Change Controls, and Audit Actions
- Provide guidance for impact assessment and investigation
- Monitor trends and ensure timely completion of actions
- undefined
- Quality Documentation & Audit Support
- Prepare and review quality documentation
- Gather and maintain required data and documents for audits and inspections
- Ensure audit readiness for both internal and external audits
- undefined
- Complaint Handling & Safety Compliance
- Ensure complaints handling, adverse event reporting, and field actions are implemented in a timely and compliant manner
- Ensure alignment with applicable procedures and regulatory requirements
- undefined
- Supplier Quality Management
- Ensure suppliers are qualified according to Purchasing Controls requirements
- Maintain supplier compliance with internal quality standards
- undefined
- Training & QMS Support
- Support training plan administration and document management system
- Contribute to organizational quality capabilities through training processes
[Leadership Competencies]
- Quality & Compliance Mindset - Strong understanding of regulatory and quality requirements with the ability to ensure compliance and improve systems
- Analytical Thinking & Problem Solving - Ability to analyze trends in CAPA, complaints, and audits and drive data-based improvements
- Stakeholder Engagement - Effective communication and collaboration with cross-functional stakeholders to ensure timely execution of quality processes
- Ownership & Accountability - Self-motivated and able to work independently with minimal supervision while driving outcomes
- Continuous Improvement Orientation - Proactively identifies improvement opportunities in QMS and supports implementation of solutions
[Qualification]
Required
- 1 ~ 3 years of work experience in the healthcare industry or a similar regulated environment
- Understanding of Quality Management System and relevant regulatory requirements
- Strong communication, presentation, and interpersonal skills
- Proficiency in both spoken and written English
- Proficiency in standard business tools (e.g. Microsoft office)
Preferred
- Proficiency in standard business tools (e.g. Microsoft office)
[Job Type]
Fixed-term (12 months Contract)
**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