글로벌 외국계 IT Solution 기업에서 다음과 같이 ‘Lead of Global Compliance and Strategy APAC’을 찾습니다.

* Title: Lead of Global Compliance and Strategy APAC

* Position: Team Leader

* Location: Seoul

[Responsibilities]

- Engage with key local regulatory agencies in the APAC region (e.g. MFDS (Korea), HSA (Singapore), TGA (Australia) etc.) and government authorities if applicable to ensure that company’s interest as a Software as a Service (SaaS) technology company serving regulated companies is considered in regulatory guidance documents and agency perceptions

- Interact directly with customers to address quality and regulatory related matters relevant to the use of technology in performing clinical trials

- Collaborate cross-functionally with other company business units (e.g. Legal, Information Technology, Product Development) to contribute to achieving company’s goals, business plan, and long-term strategy

- Fulfill the responsibilities for providing operational support to GCS-managed programs (e.g. quality incident management, internal quality system audits, customer audit/inspection needs)

[Qualification]

- Bachelor's degree required with 8 years of experience, 5 years of experience with a Master’s; or equivalent years of experience in the life sciences industry and/or medical/clinical operations.

- Requires a minimum of 2 to 3 years of experience in clinical development quality assurance

- Strong understanding of regulations governing clinical trials, including:

- Framework guidelines including ICH Good Clinical Practices (GCP) and regional distinctions

- Clinical Regulations (e.g. KGCP, specific requirements in South Korea on Clinical trials, MFDS inspections)

- Regulations on data management in clinical trials

- Computer Systems Validation

- Extensive experience in clinical trial processes and technologies, including, but not limited to a strong working knowledge of trial master file and site master files (TMF/SMF) and eTMF

- Understands quality systems processes and enablement including auditing, root cause analysis and CAPA development

- MFDS inspection experience is preferred

- Proven track record of working independently to evaluate requirements and propose solutions

- Strong teamwork spirit and good communication skills

- Fluent (read, write, speak) in English and Korean

- Residing in Seoul; able to travel within the region

Those who are interested in this opportunity, please submit your Resume (CV) in MS Word Format by email urgently.  Only qualified candidates will be contacted for interview.  All resumes not contacted will be kept in DB confidentially for future positions.

Kyung Jin KIM

CEO & Executive Search Consultant

Exdigm Inc.

Mobile: 010-8722-1272

Email: ceo@exdigm.com