GxP Quality & Compliance Specialist — 0→1 QMS Builder (Vendor-Side, AI
Benefits: Competitive salary Must-have experience 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 Requirements 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. Responsibilities 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.