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

<div class="benefits">
<div><strong>Benefits:</strong></div>
<ul>
<li>Competitive salary</li>
</ul>
</div>
<div class="trix-content">
<div>
<strong><u>Must-have experience<br></u></strong><br>
</div><ul>
<li>
<strong>Built a QMS from zero or near-zero</strong><ul>
<li>Wrote the <strong>first Quality Manual</strong>
</li>
<li>Defined deviation/CAPA processes <em>before</em> tooling existed</li>
<li>Made scoping decisions without templates or precedent</li>
</ul>
</li>
<li>
<strong>Auditee-side sponsor qualification audits</strong><ul>
<li>CRO, eClinical, clinical data platform, or regulated SaaS vendor</li>
<li>Personally authored CAPA responses <strong>and</strong> defended them</li>
</ul>
</li>
<li>
<strong>Hands-on GxP software validation</strong><ul>
<li>Custom-built systems (not Veeva/Medidata configuration only)</li>
<li>GAMP 5 Category 4 or 5 experience</li>
</ul>
</li>
<li>
<strong>Real regulatory judgment</strong><ul>
<li>Practical application of <strong>21 CFR Part 11</strong>, <strong>EU Annex 11</strong>
</li>
<li>Understands what is <em>required</em> vs. “cargo-cult compliance”</li>
</ul>
</li>
<li>
<strong>Comfort embedded with engineers</strong><ul>
<li>Works in standups</li>
<li>Answers “is this GxP-okay?” live, not via ticket queues</li>
<li>Can translate architecture → compliance artifacts</li>
</ul>
</li>
</ul><div><strong>Requirements</strong></div><ul>
<li>8 or more years of experience in GxP quality management and QMS architecture for life sciences.</li>
<li>Proficiency in GAMP 5, 21 CFR Part 11, and EU Annex 11 compliance standards.</li>
<li>Experience with building Quality Management Systems from zero within regulated SaaS or technology environments.</li>
<li>Experience in Computer System Validation (CSV) for cloud-hosted and configurable software platforms.</li>
<li>Experience with CAPA remediation, deviation SOPs, and formal audit defense for pharma sponsors.</li>
<li>Experience in validating machine learning systems and AI agentic workflows in clinical data contexts.</li>
<li>Excellent verbal and written communication skills.</li>
</ul><div><strong>Responsibilities</strong></div><ul>
<li>Author foundational Quality Manuals and SOPs for CAPA, deviations, and GxP SDLC processes.</li>
<li>Lead end-to-end CAPA remediation by tracking audit findings and delivering formal root cause responses.</li>
<li>Translate complex AI technical controls into GxP-compliant documentation artifacts and validation packages.</li>
<li>Execute validation protocols, user requirement specifications, and requirements traceability matrices for new deployments.</li>
<li>Serve as the primary subject matter expert during vendor qualification audits by defending internal documentation.</li>
<li>Determine compliance scoping for clinical data workflows and AI model versioning change impact assessments.</li>
<li>Partner with engineering teams to integrate quality standards into sprint-based software delivery cycles.</li>
</ul>
</div>
<p>Flexible work from home options available.</p>