About The Position

The Associate Director in the GCP Audit & Inspection Management department coordinates and/or conducts audits and inspection management for assigned activities. The role ensures adherence to GCP regulations, industry standards, and Vertex policies, procedures, and quality standards established in the Quality Management System. This is a remote role requiring travel about once a month.

Requirements

  • Minimum education of a BS or BA degree.
  • Typically requires 8 years of experience or an equivalent combination of education and experience.
  • Experience working in VEEVA.

Responsibilities

  • Execute routine and directed audits of GCP vendors, investigator sites, and internal processes, as assigned.
  • Engage in preparation, support, and follow-up activities for inspection readiness.
  • Support due-diligence and business development activities, as requested.
  • Participate in collaborative review of impacted SOP/WI.
  • Assess the adequacy of audit responses, including corrective and/or preventive actions.
  • May participate in process improvement initiatives.
  • Provide cross-functional support across the Vertex Quality Assurance team.

Benefits

  • Eligible for overtime pay in accordance with federal and state requirements.
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