Director - GCP/GVP Quality Assurance

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Catalyst Pharmaceuticals, Inc.

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Neurology • Neuromuscular • Pharmaceuticals • Rare Disease

51 - 200

Description

• The Director of GCP/GVP Quality Assurance will be responsible for managing the implementation and execution of the Catalyst’s Quality System and GCP/GVP Compliance at its Corporate Office. • Provide expertise in GCP/GVP, compliance interpretation, consultation, training, and recommendations to clinical development functions and the Drug Safety group. • Manage compliance risk assessments and facilitate root cause analysis, CAPA implementation, and effectiveness checks regarding GCP/GVP Operations. • Develop, implement, and execute the audit strategy and Inspection Readiness plans for Clinical and PV programs. • Execute risk-based audit programs. • Lead internal GCP/GVP audits and oversee the execution of external audits of GCP/GVP vendors. • Review and provide Quality advice on GCP/GVP-related documentation, including SOPs, study protocols, and study reports. • Manage deviations and CAPAs through completion.

Requirements

• Bachelor’s degree in life sciences is required. • A minimum of 10+ years of experience in a QA role supporting Clinical Operations and /or Pharmacovigilance departments within a biotechnology or pharmaceutical environment is required. • Strong knowledge of GCP-related regulatory requirements, US FDA, EU Directives and ICH guidelines, and Pharmacovigilance (GVPs) regulatory guidance. • Strong knowledge of developing and implementing GCP/GVP Inspection Readiness and audit programs and participating in regulatory agency inspections. • Hands-on experience in conducting clinical site and GCP/GVP vendor audits. • Experience with various databases in Clinical and/or Pharmacovigilance. • Recent FDA, Canadian, MHRA, and/or EMA compliance requirements. • Hands-on experience with electronic, paper, or hybrid document management systems. • Ability to critically evaluate and troubleshoot complex problems, attention to detail, and strong project management and organization skills. • Excellent interpersonal and communication skills. • High level of emotional intelligence. • Proficiency in Microsoft Office applications, intermediate to advanced proficiency with MS Excel.