Senior Manager/Associate Director, Clinical Quality Assurance (14-131) FibroGen
FibroGen seeks a Clinical Quality Assurance (CQA) Associate Director / Senior Manager to support the company?s Clinical Quality Assurance program. The incumbent will conduct and manage Good Clinical Practice (GCP) related quality audits (e.g., investigator site and vendor qualification); support development and improve the existing GCP related quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures and protocols. The incumbent is also responsible for developing specific internal procedures, training of staff and hosting regulatory inspections. The position involves managing global clinical quality operations and liaison of clinical quality related issues with FibroGen?s functional areas.
The successful candidate must have the ability to execute CQA tasks independently; effectively represent QA in a GCP driven team setting and interface with clinical vendors, investigator sites and regulatory agencies.
In addition, the candidate must actively participate in sustaining a level of inspection readiness of FibroGen?s clinical stakeholders and act as a catalyst for continuous process improvement.
Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements and to align with existing company policy.
Ensure clinical trials are performed in accordance with applicable study protocols and are in compliance with all applicable regulatory requirements.
Manage/conduct quality audits of investigator sites and various clinical vendors.
Manage/conduct quality audits of clinical study documents, which include investigator brochures, clinical protocols and clinical study reports, case report forms and informed consents forms.
Manage/conduct internal audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards and guidelines.
Provide expert CQA advice to stakeholders (e.g., Clinical Operations, Data Management, Pharmacovigilance, etc.) based on analysis and interpretation of GCP regulations.
Support the administration of the company?s training program by conducting GCP training to internal departments and externally, as applicable.
Manage/conduct targeted training of investigators/site staff.
Report GCP related deficiencies to QA management as well as plans for corrective and/or preventive actions (CAPA).
Assist clinical study teams in the development of CAPAs.
Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
Coordinate responses to regulatory agency inspections.
10+ years of progressive global quality assurance background in pharma/biotech and medical device industries, with a hands-on role in quality operations and quality systems
5+ years hands-on CQA/GCP Compliance experience
B.S./M.S. in relevant science field
Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for regulatory compliance.
Position requires a highly diplomatic, tactful and detail oriented individual with exceptional critical reasoning skills.
Ability to use expertise 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
Travel will be required between 30 to 50% of the time
Auditor and/or GCP certifications a plus
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