ThaiNGO

JOB SUMMARY:

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.

KEY RESPONSIBILITIES:

1. Assists with the implementing new and revised quality modules and updates standards operating procedures (SOPs).
   
   
2. Performs gap assessments to recommend changes to SOPs and ensure compliance with government regulations among functional areas.
   
   
3. Monitors and inputs data into electronic audit tracking system for documentation.
   
   
4. Participates on functional teams focused on process improvement.
   
   
5. Addresses issues, defines and implements effective corrective action to adhere to compliance regulations.
   
   
6. Supports management in developing, training and conducting procedures for functional areas that comply with government and organizational standards.
   
   
7. Works on problems of diverse scope that requires analysis of data and evaluation of identifiable factors.
   
   
8. Exercises judgment within defined policies and procedures to obtain solutions and perform duties.
   
   
9. Decisions made generally affect own job or specific functional area.
   
   
10. Performs other relevant duties as assigned.

TYPE AND NATURE OF CONTACTS:

Frequent interaction with others within and outside the organization and ability to resolve problem situations with tact.

SUPERVISORY AND BUDGET RESPONSIBILITY

None

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS:

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.

MINIMUM REQUIREMENTS

1. Bachelor’s degree or its international equivalent in Science, Public Health or related field.
   
   
2. At least 2-5 years or related experience in quality control and compliance.
   
   
3. Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
   
   
4. Must be able to read; write and speak fluent English and Thai.

This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.