Senior Regulatory Compliance Specialist

A Quality Assurance Specialist plays a vital role in ensuring compliance with regulatory standards and quality guidelines. This position is crucial for maintaining clinical trial data integrity and protecting participants' safety.

Main Responsibilities :

• Conducting audits : Perform internal and external audits to verify compliance with Good Clinical Practice (GCP) guidelines, Good Documentation Practices (GDP), company standard operating procedures (SOPs), and other relevant regulations.
• Quality Management : Evaluate and maintain the company's quality management system (QMS). Review quality events, incidents, and complaints to identify root causes and recommend corrective actions.
• Documentation and Reporting : Prepare detailed audit reports documenting findings, non-conformities, and recommendations for improvement. Present these findings to senior management and work with various teams to ensure issues are resolved.

Required Skills and Qualifications :

Benefits and Opportunities :

This role offers the opportunity to contribute to the development and implementation of quality management systems, working closely with cross-functional teams to drive business growth and improve patient outcomes.