Required Experience & Qualifications
5–8 years of hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Hands-on experience supporting GxP systems in Pharmacovigilance, Clinical, Regulatory Affairs, or a combination of these domains
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH) and data integrity expectations
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality and business stakeholders
Preferred Experience
Experience with enterprise platforms supporting PV, Clinical, or Regulatory operations
Prior role as a Validation SME, CSA Lead, or Compliance Consultant
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms