Compliance Operations Specialist

Role Overview

The Compliance Operations Specialist provides project-based support to advance a healthcare compliance program. You’ll help build and maintain compliance operational infrastructure, improve internal workflows, and organize compliance information so it’s well-governed and easy to find.

Responsibilities

• Develop, implement, and maintain scalable compliance processes, tools, and operational infrastructure
• Support priority compliance initiatives with process documentation, controls, trackers, templates, and implementation plans
• Identify opportunities to simplify, standardize, and improve compliance workflows while maintaining governance
• Assist with project planning, status tracking, and deliverable follow-through
• Support the design, build-out, and administration of an internal compliance website and document-sharing workflows
• Create and maintain an information architecture for policies, procedures, guidance, forms, training materials, FAQs, and other resources
• Establish content-management standards: ownership, version control, review cycles, archival, and access permissions
• Coordinate with Compliance, Legal, IT, and business stakeholders to ensure content is accurate, current, searchable, and user-friendly
• Monitor site content/usage and recommend improvements to increase awareness, adoption, and self-service
• Document compliance processes using process maps, SOPs, job aids, and responsibility matrices
• Translate compliance requirements into business workflows, decision points, approvals, documentation requirements, and control activities
• Support operational controls, evidence repositories, review checklists, and records-retention practices
• Help identify process gaps and opportunities for automation or improved system enablement
• Organize compliance policies/procedures/standards and maintain governance artifacts (inventories, review schedules, approval records, version histories)
• Ensure consistency in document structure, naming, metadata, formatting, and storage
• Coordinate periodic content reviews and track revisions through approval/publication
• Partner cross-functionally (Compliance, Legal, Medical Affairs, Clinical Development, Commercial, Finance, Procurement, IT)
• Gather requirements, facilitate working sessions, document decisions, and coordinate action items
• Support change-management and communications for new/updated compliance processes and tools
• Prepare project updates, operational metrics, and management-ready materials

Requirements

• Bachelor’s degree required; advanced degree or professional certification preferred
• 5+ years experience in healthcare compliance or related areas (e.g., compliance operations, ethics & compliance, legal operations, quality systems, pharma/biotech)
• Experience building/improving compliance workflows, operational controls, process documentation, and governance
• Experience organizing and administering internal websites (text truncated in posting)

Nice-to-haves

• Relevant certifications (as applicable) and experience across pharma/biotech compliance functions