HSD Lead - Korea
On-site · Seoul, Seoul, South Korea
Job Summary
Lead and oversee HSD-related Commercial Quality activities for Korea, ensuring compliant distribution, storage, handling and logistics in alignment with regulatory requirements and internal quality standards. Serve as the primary Commercial Quality contact for HSD topics in Korea and provide quality oversight for distribution, storage, handling, and lifecycle activities. Collaborate with Supply Chain, Commercial, and Regulatory Affairs to support compliant product distribution and post-market surveillance, audits, and health authority inspections as required. Drive continuous improvement to strengthen compliance and operational effectiveness. Requires a Bachelor’s degree in a related discipline and 4-6 years of progressive experience in quality/regulatory/commercial roles, with Korean language proficiency preferred.
Required Qualifications
- Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Supply Chain, or a related discipline (required)
- Advanced degree in a scientific, quality, or regulatory field (preferred)
- Typically 4-6 years of progressive experience in Quality, Regulatory, Compliance, or Supply Chain roles within a regulated industry
- Demonstrated experience supporting distribution, logistics, or post-market quality activities
- Strong understanding of quality system requirements and regulatory expectations for commercial operations
- Experience supporting audits, inspections, or regulatory assessments
- Preferred: Experience in medical devices, healthcare, or other highly regulated industries
- Familiarity with Korean regulatory and distribution quality requirements
- Experience working in a multinational or matrixed organization
- Prior experience leading or coordinating HSD or Commercial Quality activities
- Quality or Regulatory certifications preferred but not required
- Language: Korean required; English proficiency preferred
- Travel: Limited; occasional domestic travel within South Korea
- Certifications: Quality or Regulatory certifications preferred but not required
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