Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. Coordinates activities and assist with interactions during regulatory agency inspections. Interacts with regulatory agencies on defined matters. Assists with the corrective action implementation. Coordinates investigator site and clinical supplier vendor audits.
- Assists with the implementing new and revised quality modules and updates standards operating procedures (SOPs).
- Performs gap assessments to recommend changes to SOPs and ensure compliance with government regulations among functional areas.
- Monitors and inputs data into electronic audit tracking system for documentation.
- Participates on functional teams focused on process improvement.
- Addresses issues, defines and implements effective corrective action to adhere to compliance regulations.
- Supports management in developing, training and conducting procedures for functional areas that comply with government and organizational standards.
- Works on problems of diverse scope that requires analysis of data and evaluation of identifiable factors.
- Exercises judgment within defined policies and procedures to obtain solutions and perform duties.
- Decisions made generally affect own job or specific functional area.
- Performs other relevant duties as assigned.
- Ability to sit and stand for extended periods of time, ability to lift 5-50 lbs., ability to travel (domestically and internationally) as needed including weekends.
- Strong knowledge of quality standards, procedures, and regulations.
- Excellent oral and written communication skills.
- Excellent organizational and problem solving skills.
- Attention to detail and time management skills required.
- Ability to analyze and interpret data, identify errors and recommend corrective action
MINIMUM QUALIFICATION:
- At least 2-5 years or related experience in quality control and compliance.
- Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
- Must be able to read; write and speak fluent English and Thai.
PREFERRED QUALIFICATIONS:
- Master’s degree or its international equivalent in Science, Public Health or related field preferred.
- Prior work experience with quality regulations and procedures.
- Prior work experience in a non-governmental organization (NGO).
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