Associate Director/Director, Clinical QA
(POSITION CAN BE LOCATED REMOTELY)
The Clinical Quality Assurance Associate Director supports the company’s Clinical Quality Assurance program. The incumbent assists in the development and improvement of FibroGen’s clinical quality system to ensure clinical trials are conducted in accordance with relevant regulations, guidelines, procedures and protocols. The incumbent is responsible for conducting GCP compliance audits of global investigator sites, contract research organizations, clinical study reports and internal systems/processes. As a key member of the study team, the incumbent will interface with both US and China-based colleagues and provide routine oversight through scheduled audits.
Has the ability to execute CQA tasks independently; effectively represent QA in a cross-functional team setting; and interface with clinical vendors, investigator sites and regulatory agencies in a professional yet effective manner.
Possesses excellent skills in negotiation, written/verbal communication, and independent problem solving. Has a solid understanding of the clinical development process, and the ability to practically apply domestic and international GCP regulations and guidance.
Actively participates in sustaining a level of inspection readiness of FibroGen’s clinical stakeholders and acts as a catalyst for continuous process improvement.
• Develop GCP related quality system SOPs in compliance with all applicable regulatory requirements, aligning with existing company policy.
• Ensure clinical trials are performed in accordance with study protocols and are in compliance with all applicable regulatory requirements.
• Conduct quality audits of investigator sites and various clinical vendors.
• Review and approve corrective/preventive actions to reported audit observations, and ensure proper follow-up documentation is created.
• Conduct quality reviews or audits of clinical study documents, which include investigator brochures, clinical protocols/amendments, clinical study reports, case report forms and informed consents forms.
• 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.
• Conduct targeted training of investigators/site staff when required.
• 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 regulatory agency inspections.
• Ideal candidate may work remotely but will be expected to travel up to 30% (domestic and/or international)
• 10+ years of clinical quality assurance auditing experience, preferably for a Sponsor company or mid-large size CRO. B.S./M.S. in a 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.
• A highly diplomatic, tactful and detail-oriented approach 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, and develop creative and pragmatic solutions to GCP compliance risk areas
• RQA-GCP certification is preferred