We are seeking a Clinical Quality Assurance Lead for a 2-year-regular position (renewable) to work within the Quality Mangement Department at the International Vaccine Institute in Seoul, Korea. (Duty station : Seoul, Korea)

Job Description

This job is responsible for planning and conducting independent audits to assess compliance with regulations, guidelines, and standard operating procedures. In addition, prepare and distribute reports of observations to supervisor, operations staff, management and customers. Provide consultation and training in interpretation of regulation, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulation, guidelines, industry standards and procedures.

Key Roles & Responsibilities

1. Subject Matter Expert (SME) support of Clinical Quality Management & related system development

• - Ability to work independent and demonstrate sound judgement related
• - Provide support to Clinical Quality Assurance (CQA) by working closely with CQA management
• - Support CQA efforts through attendance of internal meetings supporting clinical research at IVI and communicating QM related outcomes of such meetings to quality management
• - Interact effectively with clinical quality stakeholders (both internal and external to IVI) to include but not limited to members of clinical operations, project management, vendor management and vendor quality assurance departments.
• - Act as a Subject Matter Expert (SME) and as primary point of contract for CQA questions and concerns reported to IVI QM, with the ability to identify and triage significant compliance and safety risks related to clinical research
• - Remain current with and communicate to QM changes in applicable regulatory requirements, and guidelines for the assessment and implementation of continuations quality improvements within IVI QM and to support IVI stakeholders.
• - Provide on-going inspection readiness oversight to IVI QM and IVI stakeholders inclusive of trainings, mock-inspection support and regulatory inspection & general audit support.

2. Quality Audit Conduct & Management

• - Plan, schedule, conduct, report and close audit activities (including CAPA management) for Investigator Site audit, Vendor Qualification audit, Clinical Study Reports, Essential documents audit, Trial Master File and for-cause audits etc. in support of GxP activities with primary focus on GCP.
• - Manage quality consultants and related activities (as applicable)
• - Provide consultation in interpretation of regulation, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulation, guidelines and procedures
• - Create quarterly quality metrics for reporting at Quality Standards Committee (QSC) meeting and to executive management as needed.
• - Quality Coaching – train IVI employees on regulatory compliance, Inspection/audit readiness, quality practices and inspection readiness.
• - Manage Quality Issues- review, approve investigations, Root Cause Analysis (RCA), Corrective Actions and Preventive Actions (CAPA) and Effectiveness Check (EC) plan and track through closure for quality events arising from Quality issues (escalation of quality events from stakeholders), Audits, Inspections or during similar QA activities.
• - May perform laboratory audits (e.g., GLP, GCLP, Bioanalytical and clinical/medical labs) when needed

Job Requirements and Qualifications

1. Education Requirements

• - Bachelor’s degree, Master’s degree or equivalent preferred

2. Related Field Work Experience

• - 5+ years in Clinical Trial Coordination, Monitoring and Quality Experience in relation to conducting GxP quality audits with focus on GCP activities and preparation of inspection and partner audits in medical research organization

3. Technical and Professional Skills / Knowledge

• - Expert knowledge of GCP, familiarity with GCLP and GMP

4. Language Proficiency

• - Fluency in English (spoken and written)
• - Korean is beneficial