临床质量总监Clinical QA Director(US)-MRCT

公司介绍

总部在中国，目前有1-3期项目

职位描述

Clinical QA Director (US) – MRCTLocation: United States (Remote / Hybrid)Reports to: CMO / VP Clinical OperationsEmployment Type: Full-timePosition SummaryResponsible for clinical quality assurance of the US portion of Multi-Regional Clinical Trials (MRCT). Ensure compliance with GCP, ICH-GCP, FDA regulations, and applicable global standards. Lead clinical audit activities and ensure data integrity and reliable reporting across all stages of data processing.

职位要求

Key Responsibilities Clinical Quality System Establish and maintain clinical quality system, including QA responsibilities, deviation investigation, and clinical trial report review and archiving processes. Develop and update QA SOPs in line with FDA, ICH-GCP, and NMPA requirements. Track regulatory changes and assess impact on the quality system. Clinical Audit System Establish and maintain the audit system to ensure data and result reports are reviewed. Develop annual audit plans; conduct site, vendor, and internal process audits. Issue audit reports and track CAPA to closure. Manage third-party audit resources as needed. Data Quality Control Ensure quality control at every stage of data processing to guarantee reliable data and correct processes. Support quality review of key documents (CSR, registration dossiers, etc.). Establish and monitor quality metrics for continuous improvement. Vendor / GCP Company Management Evaluate, audit, and oversee quality systems of GCP vendors (CROs, SMOs, central labs, etc.). Manage vendor qualification, periodic audits, and performance assessment. Track and resolve vendor quality issues. Pharmacovigilance Quality Familiar with PV processes; ensure safety reporting compliance with regulations. Support quality review of PV SOPs and audits/inspections. Inspections Lead preparation and support for FDA and other regulatory inspections. Coordinate mock inspections and drive CAPA closure for inspection findings. Cross-functional Collaboration Collaborate with Clinical Operations, Medical, Data Management, Biostatistics, Regulatory, and PV teams to provide quality support.   Qualifications Education Bachelor's degree or above in medicine, pharmacy, biology, life sciences, or related field. Master's or above preferred.   Experience 5+ years of clinical QA experience. Experience managing GCP companies (CROs/SMOs). Full-cycle clinical trial QA experience (Phase I–IV). Experience with FDA inspections preferred. Experience in MRCT quality management preferred.   Knowledge & Skills In-depth knowledge of GCP, ICH-GCP, and FDA regulations. Familiar with pharmacovigilance processes and regulations (e.g., GVP). Proficient in audit processes, methodologies, and CAPA management. Strong SOP writing and review skills. Fluent in English (written and verbal).   Core Competencies High integrity and compliance mindset. Strong analytical and problem-solving skills. Excellent communication and cross-functional collaboration. Ability to work independently in a fast-paced, multi-project environment.   Preferred Experience in large pharma or reputable CRO in clinical QA management. Experience in quality review of registration dossiers. Quality certification (e.g., CQA, ISO 9001 auditor). Chinese language skills preferred. Understanding of Chinese culture preferred.   Compensation Competitive, commensurate with experience.

公司介绍

职位描述

职位要求

Emily Liu