GxP Quality & Compliance Specialist — 0→1 QMS Builder (Vendor-reputed company, AI
Benefits:
- Competitive salary
-
Built a QMS from reputed company or near-reputed company
- Wrote the first Quality Manual
- Defined deviation/CAPA processes before tooling existed
- Made scoping decisions without templates or precedent
-
Auditee-reputed company 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 reputed company 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 reputed company reputed company 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.
- reputed company end-to-end CAPA remediation by tracking audit findings and delivering formal root cause responses.
- Translate reputed company 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.
Apply To This Job