GxP Quality & Compliance Specialist — 0→1 QMS Builder (Vendor-Side, AI

• Competitive salary

• Built a QMS from zero or near-zero
  • Wrote the first Quality Manual
  • Defined deviation/CAPA processes before tooling existed
  • Made scoping decisions without templates or precedent
• Auditee-side sponsor qualification audits
  • CRO, eClinical, clinical data platform, or regulated SaaS vendor
  • Personally authored CAPA responses and defended them
• Hands-on GxP software validation
  • Custom-built systems (not Veeva/Medidata configuration only)
  • GAMP 5 Category 4 or 5 experience
• Real regulatory judgment
  • Practical application of 21 CFR Part 11, EU Annex 11
  • Understands what is required vs. “cargo-cult compliance”
• Comfort embedded with engineers
  • Works in standups
  • Answers “is this GxP-okay?” live, not via ticket queues
  • Can translate architecture → compliance artifacts

• 8 or more years of experience in GxP quality management and QMS architecture for life sciences.
• Proficiency in GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance standards.
• Experience with building Quality Management Systems from zero within regulated SaaS or technology environments.
• Experience in Computer System Validation (CSV) for cloud-hosted and configurable software platforms.
• Experience with CAPA remediation, deviation SOPs, and formal audit defense for pharma sponsors.
• Experience in validating machine learning systems and AI agentic workflows in clinical data contexts.
• Excellent verbal and written communication skills.

• Author foundational Quality Manuals and SOPs for CAPA, deviations, and GxP SDLC processes.
• Lead end-to-end CAPA remediation by tracking audit findings and delivering formal root cause responses.
• Translate complex AI technical controls into GxP-compliant documentation artifacts and validation packages.
• Execute validation protocols, user requirement specifications, and requirements traceability matrices for new deployments.
• Serve as the primary subject matter expert during vendor qualification audits by defending internal documentation.
• Determine compliance scoping for clinical data workflows and AI model versioning change impact assessments.
• Partner with engineering teams to integrate quality standards into sprint-based software delivery cycles.

Flexible work from home options available.