Compliance Analyst (Part Time Contractor)

Unlearn•San Francisco, CA

About The Position

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.

Requirements

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

Nice To Haves

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

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