Compliance Systems Supervisor (34537)

Job Summary

The Compliance Systems Supervisor is responsible for strategic implementation and support for RA/QMS and cross-functional process improvements to ensure compliance. This role oversees department administrative operations and provides governance over regulatory software compliance, including Computer Software Assurance (CSA) activities.

Essential Functions, Duties, And Responsibilities

• Manage departmental administrative operations, including budget oversight, system access governance, onboarding strategy, and digital workspace optimization (e.g., SharePoint, Wrike).
• Evaluate and interpret regulatory and quality data to inform strategic decisions and ensure continuous compliance within RA/QMS systems and processes.
• Champion and drive data management strategies for the RA/QMS department, identifying opportunities for automation, efficiency, KPI monitoring, and risk mitigation.
• Leverage Power BI and similar analytics tools to design, maintain, and present compliance dashboards that communicate system performance, KPI trends, and regulatory status to leadership and cross-functional stakeholders.
• Facilitates and governs CSA validation activities. Ensure alignment with CSA principles, identify opportunities to simplify validation activities while maintaining compliance.
• Own and maintain the CSA governance framework, including procedures, templates, and decision trees for risk-based assurance activities.
• Lead risk assessments, including review of software features, functions, and intended use, to determine appropriate CSA strategies for new and existing systems.
• Maintains validation/assurance documentation, and ensures regulatory compliance (test protocols, traceability matrices).
• Ensure audit readiness by maintaining compliant validation and quality system documentation and serving as a subject matter expert during regulatory and compliance audits.

Continuous Improvement

• Identify opportunities to streamline processes and improve system usability and compliance.
• Develop and maintain CSA training and guidance to internal teams.
• Track and report Compliance Team project metrics and KPIs to leadership, utilizing Power BI and other data visualization tools to present actionable insights in a clear and accessible format.

Qualifications

• 4-year degree plus 4 years of relevant experience.
• Previous work as a leader in a regulated company.
• Documented training to ISO 13485.
• Proficient user of Microsoft Power Platform, including Power BI; experience interpreting, analyzing, and presenting data and analytics using Power BI and similar tools.
• Strong knowledge of FDA regulations, ISO standards, and CSA methodologies.
• Proven experience managing cross-functional projects in a regulated environment.
• Excellent organizational, communication, and leadership skills.