Compliance Analyst (Part Time Contractor)

Compliance Analyst (Part Time Contractor) OUR MISSION AND VISION Unlearn exists to transform clinical development by making every trial smarter. We harness data, AI, and digital twins to enable faster, more robust studies that bring life-saving treatments to patients faster. This mission drives everything we do as we partner with biopharmaceutical companies to redesign how clinical trials are planned, run, and analyzed. We are defining the future of clinical development with unmatched scientific credibility, replacing uncertainty with AI-powered precision so decisions are clearer and trials are stronger. We don’t just disrupt the pharmaceutical industry, we create lasting change. We believe AI will define the future of medicine, and we are committed to building that future responsibly, rigorously, and in close collaboration with our partners in clinical development. ABOUT OUR TEAM We come from a variety of backgrounds ranging from machine learning to marketing—but regardless of where we come from, Unlearners share some common traits: - Unlearners are ambitious; we aren’t intimidated by big, challenging goals. - Unlearners are disciplined experimenters; we break down our big goals into smaller chunks and meet as often as necessary to track our velocity and iterate quickly. - Unlearners are gritty; we never give up, setbacks just make us try harder. - Unlearners are receptive to new ideas; in fact, we hate being stuck with the status quo - Unlearners are storytellers; sharing information with each other and with the world is super important, too important to be boring. And, last but not least, - Unlearners are team-oriented; we put the mission first, the company second, the team third, and individuals last. Headquartered in San Francisco, Unlearn was founded in 2017 by a team of world-class machine learning scientists. We have raised venture capital from top tier investors such as Altimeter, Insight Partners, Radical Ventures, 8VC, DCVC, and DCVC Bio, and completed our $50 million Series C in January 2024. If our purpose and culture resonate with you, we invite you to apply. CORE RESPONSIBILITIES QMS DOCUMENTATION & EVIDENCE MAINTENANCE - Track document control processes, including version management, review cycle tracking, and filing of approved documents - Collect, organize, and maintain audit-ready evidence across all active compliance frameworks - Update and maintain quality metrics dashboards and trackers as directed - Ensure QMS documentation is current, properly formatted, and accessible for audit purposes - Track open audit findings and maintain status logs through to documented closure COMPLIANCE EVIDENCE COLLECTION & AUDIT SUPPORT - Help collect and organize evidence packages for SOC 2, ISO 27001, GDPR, and other framework audits - Help complete and respond to customer security questionnaires and due diligence requests - Track audit finding remediation status, follow up with responsible parties on deadlines, and document corrective actions upon completion - Prepare audit schedules, coordinate logistics for auditor visits, and assemble requested documentation VALIDATION DOCUMENTATION & CHANGE CONTROL SUPPORT - Maintain validation documentation, traceability matrices, and protocol records - Support validation activities by preparing test plans, recording results, and filing completed protocols - Work through the existing validation documentation backlog, prioritizing as directed CAPA & NCR TRACKING - Track the CAPA and Deviation lifecycles from initiation through closure, ensuring documentation is complete at each stage - Work through the backlog of overdue CAPAs and Deviations, following up with owners on outstanding action items - Document root cause analysis findings and corrective actions as provided by subject matter experts - Maintain CAPA/Deviation logs and produce status reports on aging, closure rates, and overdue items TRAINING RECORD MANAGEMENT - Track training completion r ... (truncated, view full listing at source)