AD/Director QA

This position will play a vital role in directing the company's Clinical QA program. Focus includes conducting internal and external Clinical audits to ensure the clinical trials are conducted in accordance with GCP regulations and ICH guidelines.The incumbent is responsible for developing internal and external auditing plans and activities, training of staff as needed and in the development/maintenance of GCP related quality systems. Job Duties * Develops quality system policies and SOPs for Clinical QA in compliance with applicable regulatory requirements and best industry practice. * Ensures all clinical trials are performed in accordance with study protocols, and are in compliance with GCP and ICH guidelines. * Conducts Good Clinical Practice compliance audits of a sampling of Investigator sites, Clinical Research Organization (CRO) facilities and vendors, in accordance with Audit Plans. * Reports significant quality deficiencies to QA management. * Conducts internal audits to ensure compliance with Department Guidelines and Procedures, and Good Clinical Practice and ICH Guidelines. * Provides expert QA advice to Clinical Operations based on analysis and interpretation of updates to GCP regulations to assure best Clinical/QA practices. * Supports the administration of the company's training program, and conducts Good Clinical Practice training to internal Clinical Departments and externally, if applicable. * Conducts or manages targeted training of investigators/site staff. * Manages and assists Clinical Working Groups in the implementation of Corrective Action Plans. * Coordinate responses to regulatory agency inspections. * 30%+ travel required. * Perform data integrity audits. * Manage the clinical CAPA and Deviation systems The ideal candidate will have 7+ years of experience in the Pharmaceutical/Biotech industry and be ready to join this exciting company as it moves towards commercialization. Thanks you for your interest.

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com