Nathaniel Martin

About Nathaniel Martin

Experienced leader in quality program development, implementation, and operations within the pharmaceutical and government sectors. Focused on simplified, risk-based approaches that ensure compliance with international regulations. Quality initiatives span post-marketing, Phase 2 & 3 clinical trials, pharmacovigilance systems, and hyperbaric treatment therapies. Execution of readiness activities have ensured successful regulatory authority inspections from FDA, MHRA, EMA, PDMA, and DKMA. Key strengths consist of executive-level communication, situational awareness, decisiveness, root cause analyses, risk assessments, cross-functional communication, and process development.

Experience

1. Senior Manager, Gxp Quality Assurance

   Verona Pharma

   Apr 2023 — Present

   Configure, implement, and manage Verona’s Quality Management System (eQMS): Audits, Document Management, Training, Quality Issues, Change Management- Design, implement, and manage strategic and tactical risk-based audit planning across all disciplines (GVP, GMP, GCP, GDP). Full scope of vendor audit program from drug development through commercial services, US and EU/EEA- Lead auditor for third-party logistics, specialty pharmacies, computerized systems, and internal functions. Audit team member for vendor and internal pharmacovigilance audits- Develop and conduct User Acceptance Testing for GxP internal computerized systems- Establish and manage quality oversight program for internal and vendor GxP computerized systems (e.g, eQMS, safety database, eTMF)- Implement and manage role-based training initiatives to support commercial launch initiatives.

Education

• Southern Illinois University, Carbondale

  Bachelor of Science - BS, Workforce Education/Occupational Training & Organization

• Rutgers Business School

  mini-MBA, Business Management for Military and Veterans