Compliance Operations Specialist

Role Overview

The Compliance Operations Specialist provides project-based support to advance a healthcare compliance program. You will help build and maintain compliance infrastructure, improve internal systems and workflows, and create well-governed approaches for organizing and sharing compliance information.

Responsibilities

• Develop, implement, and maintain scalable compliance processes, tools, and operational infrastructure
• Provide project/overflow support across priority compliance initiatives (process documentation, controls, trackers, templates, and implementation plans)
• Improve compliance workflows by simplifying and standardizing processes while maintaining governance and documentation
• Support project planning, status tracking, issue identification, and follow-through on deliverables
• Design, build-out, and administer an internal compliance website and related document-sharing workflows
• Organize compliance resources (policies, procedures, guidance, forms, training materials, FAQs) into an intuitive information architecture
• Define content-management standards (ownership, version control, review cycles, archival practices, 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 current-state and future-state compliance processes (process maps, SOPs, job aids, responsibility matrices)
• Translate compliance requirements into practical business workflows, decision points, approvals, documentation requirements, and control activities
• Support operational controls: evidence repositories, review checklists, and records-retention practices
• Identify process gaps, duplicative steps, unclear ownership, and opportunities for automation
• Maintain policies/procedures/standards and governance materials (document inventories, review schedules, approval records, version histories)
• Ensure consistency in document structure, naming conventions, metadata, formatting, and storage locations
• Coordinate periodic content reviews and track revisions through approval and publication
• Partner with multiple functions (Compliance, Legal, Medical Affairs, Clinical Development, Commercial, Finance, Procurement, IT) and facilitate working sessions
• Support change-management and communication for new/updated compliance processes and tools
• Prepare management-ready updates, operational metrics, and project materials

Requirements

• Bachelor’s degree required
• 5+ years of experience in healthcare compliance/compliance operations/ethics and compliance/legal operations/quality systems, or related pharma/biotech work
• Experience building/improving compliance workflows, operational controls, process documentation, and governance practices
• Experience organizing and administering internal websites and document-sharing workflows

Nice to Have

• Advanced degree or relevant professional certification preferred