Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases.  Our mission is to improve the lives of patients with rare and ultra-rare diseases.  At Catalyst, we utilize leading-edge science in search of therapies that will improve the lives of those who suffer from rare-diseases, often without any therapeutic options. We believe that no other field of medicine holds as much promise and makes such a significant impact on patents’ lives as the development of novel orphan drugs.

 

Position Summary

The Sr Manager / Assoc. Director of 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.

 

Principal Responsibilities

The Sr Manager / Assoc. Director of Quality Assurance will work to ensure the roll out and on-going compliance of Catalyst quality systems as well as associated procedures and standards.  

Implement and maintain a GxP compliant Quality Management System (QMS) by facilitating related including, but not limited to:

·        Manage compliance risk assessments and facilitate root cause analysis, CAPA implementation and effectiveness checks.

·        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 execution 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.

·        Act as an administrator for Catalyst’s electronic document management system.

·        Drive training program changes that will enhance quality of the program and compliance metrics.

·        Partner with subject matter experts and functional managers to develop training content and curricula structure based on training needs analysis.

·        Support Management Quality Reviews.

·        Partner with the Executive Director of Quality in creation Key Performance Indicators and Quality Metrics.

Required

• Educational: Applicable Medical, Healthcare or Biological Sciences degree required.
• A minimum of 8+ years of experience in a GxP biotechnology or pharmaceutical environment is required.
• Strong knowledge of GCP related regulatory requirements US FDA, EU Directives and ICH guidelines and Pharmacovigilance (PV) regulatory guidance.
• Strong knowledge in development and implementation of GCP/GVP Inspection Readiness and audit programs, and participation in regulatory agency inspections.
• Hands on experience in conducting clinical site and vendor auditing processes with recent FDA, Canadian and/or EMA compliance requirements.
• Hands-on experience with electronic, paper or hybrid document management system.
• A minimum of 2 years of work experience in an LMS.

• Ability to critically evaluate and troubleshoot complex problems and attention to detail. Strong project management and organization skills.
• Excellent interpersonal and communication skills.
• High level of emotional intelligence.
• Proficiency in Microsoft Office applications.