Position Summary:

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. The candidate will be the primary Quality contact for all GCP/GVP related matters and will have strong experience in GxPs, relevant FDA regulations as well as the ability to function independently.

Responsibilities:

• 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, but not limited to, SOPs, study protocols, study reports, IB, study execution plans, clinical site selections, Safety Management Plans, PSMF, Aggregate reports, etc. 
• Assists in readiness preparation, and/or directly supports regulatory agency inspection 
• Supports evaluation of new regulations and potential implications for Catalyst and/or R&D vendors
• Evaluates, writes, and/or reviews standard operating procedures, and performs other activities in support of an integrated cross-functional QMS
• Supports deviation identification, reporting, and CAPA development
• Lead investigations into significant quality issues, scientific misconduct, and suspected serious breaches of GCP or GVP; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate. Manage deviations and CAPAs through the completion 
• Partner with subject matter experts and functional managers to advise on training content and curricula structure based on training needs analysis. 
• Support Management Quality Reviews. 
• Partner with the VP of Quality in creating Key Performance Indicators and Quality Metrics. 

Education/Experience/Skills:

• 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. 

EEO Statement

Catalyst Pharmaceuticals is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.  

Recruitment & Staffing Agencies: Catalyst Pharmaceuticals does not accept unsolicited agency resumes. Agency resumes will only be accepted if the agency is formally engaged by Catalyst Human Resources.