Manager/Senior Manager, Clinical and PV Quality

Responsibilities

• Provide GCP and GVP oversight of clinical trial activities and related records to ensure compliance with global regulations (FDA, Health Canada, EMA, MHRA)
• Partner with Clinical Operations and Pharmacovigilance to drive a "first time right" approach to compliance
• Support the development and improvement of corporate quality systems for early, mid, and late phase clinical programs
• Provide expertise and guidance on applicable regulations to specialty pharma and clinical development teams
• Identify and address GCP/GVP compliance issues and ensure readiness for regulatory inspections
• Develop and implement a risk-based GCP and GVP audit program
• Execute internal and external audits regarding adherence to SOPs, policies, and contractual agreements
• Facilitate GCP/GVP/GxP training for relevant personnel
• Lead investigations into significant departures from GVP/GCP, including serious breaches or scientific misconduct
• Review and provide input to clinical documentation such as protocols, study reports, and IBs
• Develop and measure quality metrics to drive consistent standards across the organization

Requirements

• Bachelor’s degree in a scientific discipline or field
• 5+ years of experience within the pharmaceutical and R&D industry
• Minimum of 3 years hands-on GCP and/or GVP QA experience
• Extensive knowledge of ICH, GCP, and GVP guidance documents
• Experience in a compliance role
• Proven ability to manage complex projects and influence senior leaders
• Proficient MS Office skills

Preferred Qualifications

• Experience hosting or managing GCP and/or GVP inspections
• Experience in clinical operations and handling trial essential documents

About the Company

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and developing differentiated products with a focus on novel mechanisms of action.