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 rates across the organization and escalate overdue assignments - Maintain training records and documentation for audit readiness - Help identify necessary updates for training materials to reflect current regulatory requirements and internal policy changes as directed - Support onboarding by ensuring new employees complete required compliance training modules PRIVACY & DATA PROTECTION SUPPORT - Maintain records of data processing activities and keep privacy documentation current - Process data subject requests following established procedures and track through to completion - Clear the current queue of pending privacy reviews using established review criteria - Assist with evidence collection for privacy-related compliance requirements COMPLIANCE REPORTING & METRICS TRACKING - Compile and update compliance dashboards, audit readiness scorecards, and certification timeline trackers - Monitor and report on key compliance KPIs, including CAPA closure rates, training completion, audit finding resolution, and evidence currency - Establish consistent reporting cadences and formats to close existing reporting gaps QUALIFICATIONS REQUIRED - 2–4 years of experience in compliance, quality assurance, or regulatory support within a technology, SaaS, or life sciences environment - Working familiarity with SOC 2, 21 CFR Part 11, and/or Annex 11 evidence requirements - Experience with audit evidence collection, document control, and compliance documentation maintenance - Demonstrated ability to track and manage CAPA/NCR documentation and training records - Strong organizational skills with attention to detail and the ability to manage multiple tracking systems simultaneously - Clear written communication skills for maintaining documentation and responding to questionnaires - Self-directed and able to manage a task queue in a fast-paced, resource-constrained environment PREFERRED - Exposure to SOC 2, ISO 27001 and/or ISO 42001 documentation or implementation support - Familiarity with privacy regulations (GDPR, CCPA, or equivalent) and data subject request processing - Experience responding to customer security questionnaires and due diligence requests - Background in GxP-regulated or enterprise SaaS environments - Relevant certifications such as CISA, ISO 27001 Lead Implementer, or ASQ CQA are a plus PART-TIME TO FULL-TIME TRANSITION CRITERIA This role is designed to begin as a part-time position (approximately 20 hours per week) with a planned transition to full-time based on demonstrated demand and business triggers, including: - Sustained compliance workload exceeding part-time capacity for two or more consecutive months - Initiation of ISO 27001 or ISO 42001 certification preparation - Growth in customer base driving increased volume of security reviews and audit requests - Expansion of regulatory scope requiring additional compliance coverage The transition decision will be evaluated jointly by the hiring manager and executive leadership, with the expectation that full-time conversion will occur within 6–12 months of the start date based on current growth trajectory. BENEFITS & PERKS The following benefits and perks are for full time roles only. - Generous equity participation - 100% company-covered medical, dental, & vision insurance plans - 401k plan with matching - Flexible PTO plus company holidays - Annual company-wide break December 24 through January 1 - Commuter benefits - Paid Parental Leave Unlearn is an equal opportunity employer.  At Unlearn, we are committed to building a diverse and inclusive workplace, because inclusion and diversity are essential to achieving our mission. If you’re excited about this role, and your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply nevertheless.