Catalyst Pharmaceuticals Inc
Director, GCP/GVP Quality Assurance
Catalyst Pharmaceuticals Inc, Howey-in-the-Hills, Florida, United States,
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.
Assist in readiness preparation, and/or directly support regulatory agency inspection.
Support evaluation of new regulations and potential implications for Catalyst and/or R&D vendors.
Evaluate, write, and/or review standard operating procedures, and perform other activities in support of an integrated cross-functional QMS.
Support 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 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.
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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.
Assist in readiness preparation, and/or directly support regulatory agency inspection.
Support evaluation of new regulations and potential implications for Catalyst and/or R&D vendors.
Evaluate, write, and/or review standard operating procedures, and perform other activities in support of an integrated cross-functional QMS.
Support 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 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.
#J-18808-Ljbffr