Senior Manager, Compliance & Audit

mpathic

. Own and scale mpathic’s compliance and audit programs .

Posted 10/6/2026full-timeRemote • United StatesSenior💰 $140,000 - $180,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in IT compliance, audit management, and regulatory frameworks, with a strong focus on FDA 21 CFR Part 11 and GxP data integrity requirements. Proficient in leading audits, managing compliance programs, and automating evidence collection to ensure adherence to industry standards.

Highest-signal resume keywords

IT Compliance ManagementFDA 21 CFR Part 11 ExpertiseGxP Data IntegritySOC 1 and SOC 2 AuditsISO/IEC 27001 Certification

ATS Keywords

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Hard Skills

Audit ManagementRisk-Based ValidationValidation PlansRequirements TraceabilityEvidence Collection AutomationControl MappingChange ManagementData HandlingInternal AuditsPolicy Writing

Soft Skills

CommunicationCollaborationProblem-SolvingLeadership

Tools & Technologies

GRC PlatformAWSGCPAzureCI/CD Tools

Certifications & Qualifications

CISAISO/IEC 27001 Lead AuditorISO/IEC 42001 Lead AuditorASQ CQACISSP

Industry Keywords

GxPAI GovernanceFDA GuidanceISO/IEC 42001NIST AI RMFEU AI ActAudit TrailsElectronic SignaturesALCOA+ PrinciplesNonconformities

Tech Stack

Tools & technologies

AWSAzureCloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Own and scale mpathic’s compliance and audit programs
Plan and run the annual audit and certification cycle for SOC 1, SOC 2, ISO/IEC 27001, ISO/IEC 42001, and Part 11 readiness
Select auditors, define scope, collect evidence, manage fieldwork and management responses, and deliver final reports or certificates
Own Part 11 compliance for systems creating, modifying, or storing regulated records
Maintain system inventories and GxP impact assessments
Lead risk-based validation and keep validation documentation current through releases and system changes
Maintain a unified control set mapped across applicable frameworks
Run risk-based internal audits, ISO-required internal audits, and management reviews; track nonconformities and CAPAs through closure
Partner with engineering and delivery teams on change management, code review, access reviews, release validation, and data handling
Automate evidence collection where possible and monitor control health
Maintain mpathic’s ISO/IEC 42001 AI management system, including AI risk and impact assessments and model lifecycle control documentation
Own security questionnaires, customer and sponsor quality audits, compliance-related RFP and contract responses, and the trust center
Own the GRC platform and integrations, including control mappings, automated evidence collection, and policy workflows
Maintain certification and regulatory policies and SOPs
Deliver compliance training, including Part 11 and GxP training
Monitor FDA guidance, AI governance requirements, and applicable data privacy laws and translate changes into recommendations

Requirements

What you’ll need

7+ years in IT compliance, GRC, audit, or computerized systems validation, including direct ownership of external audits from scoping through final report or certification
Hands-on experience applying FDA 21 CFR Part 11 and GxP data integrity requirements to software or SaaS systems, including audit trails, electronic signatures, access controls, record retention, and ALCOA+ principles
Familiarity with FDA Computer Software Assurance (CSA) guidance, GAMP 5, and EU Annex 11 is a strong plus
Experience writing or leading validation plans, requirements traceability, risk-based test evidence (IQ/OQ/PQ or CSA-style), and validation summary reports
Experience supporting customer or sponsor audits of validated systems
Experience leading or supporting SOC 1 and SOC 2 Type II examinations and ISO/IEC 27001 certification or surveillance audits
Experience with ISO/IEC 42001 or other AI governance frameworks, including NIST AI RMF or the EU AI Act, is a strong plus
Comfortable reviewing cloud configurations across AWS, GCP, or Azure; IAM policies; CI/CD and change management records; logging; and infrastructure as code
Able to plan and execute internal audits, sample and evaluate evidence, write clear findings, and drive CAPAs through closure
Comfortable representing mpathic with external auditors, certification bodies, customers, and sponsor quality teams
Able to write policies, findings, and customer responses
Certifications such as CISA, ISO/IEC 27001 Lead Auditor or Lead Implementer, ISO/IEC 42001 Lead Auditor, ASQ CQA, or CISSP are a plus