Associate Director/Director, Clinical Quality Assurance FibroGen
This position will play an essential 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 will be responsible for ensuring clinical studies are performed in compliance with FibroGen procedures and protocols. The incumbent is also 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 including, CAPA and Deviation management.
Develops quality system policies and SOPs for Clinical QA in compliance with applicable regulatory requirements and best industry practice.
Ensures clinical trials are performed in accordance with applicable study protocols, and are in compliance with Good Clinical Practice 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.
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.
Reports significant quality deficiencies to QA management.
Manages and assists Clinical Working Groups in the implementation of Corrective Action Plans.
Coordinate responses to regulatory agency inspections.
25 - 35% travel required.
Perform data integrity audits.
Perform for cause GCP audits
Manage the clinical CAPA and Deviation systems
Must have a BS/BA or MS/MA degree in a related discipline.
A minimum 7 years of related experience; or MS/MA degree in related discipline and minimum five 5 years of related clinical QA experience
Current and strong working knowledge interpretation/implementation of Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
Excellent verbal and written communication skills, ability to work well in teams or independently and able to prioritize work, manage multiple projects while maintaining quality and advocate for compliance.
Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented
Experience working with clinical sites
Experience in developing SOPs in for quality assurance and compliance.
Experience with clinical trials at all phases of development.
Experience with creating quality systems in a small company environment
Uses expertise or unique knowledge and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways
Ability to deal with ambiguity, creative and pragmatic approach to problem solving.
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