Compliance Analyst (Part Time Contractor)

Unlearn.AI Inc

San Francisco, CA

JOB DETAILS
SKILLS
American Society for Quality (ASQ), Analysis Skills, Artificial Intelligence (AI), Backlog Prioritization, Biology, Biotech and Pharmaceutical, Boring, CISA - Certified Information Systems Auditor, Change Control, Clinical Trial, Code of Federal Regulations, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Data Processing, Detail Oriented, Diversity, Document Control, Document Tracking, Documentation, Drug Development, Environmental Sciences, GxP, ISO (International Organization for Standardization), Information/Data Security (InfoSec), Insurance Regulations, Machine Learning, Marketing, Medicine, Metrics, Needs Assessment, Onboarding, Organizational Skills, Privacy Controls, Privacy Regulations, Procedure Development, Quality Assurance, Quality Management, Quality Metrics, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Dashboards, Sales/Support Engineering (SE), Scorecarding, Security Auditing, Software as a Service (SaaS), Support Documentation, Systems Administration/Management, Technical Support, Test Plan/Schedule, Traceability, Validation Documentation, Writing Skills
LOCATION
San Francisco, CA
POSTED
30+ days ago

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.

About the Company

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Unlearn.AI Inc