Clinical Software Audit Manager

Your responsibilities will include: Develop and maintain audit tools, checklists, and timelines; implement and track corrective action plans, using metrics to identify trends and drive process improvements. Collaborate with R&D, Clinical, Sourcing, Supplier Controls, Software Quality Assurance, Regulatory Affairs, and Data Science teams to support vendor management, audit readiness, and compliance oversight. Support governance and corrective action management, ensuring that all issues are resolved in line with organizational and regulatory expectations. Minimum Bachelor's degree in computer science, engineering, life sciences, or a related field; advanced degrees preferred. Minimum of 5 years' experience auditing software and clinical vendors, with demonstrated expertise in regulatory compliance, software validation, and risk analysis. Strong background in ISO 13485, IEC 60601, FDA guidelines, ISO 14155, and 21 CFR Part 11. Demonstrated experience with audit tool development, metrics tracking, and process improvement. Minimum of 3 years' experience in a managerial or leadership role within clinical, auditing, quality assurance, or regulatory compliance. Proven ability to lead, mentor, and develop teams, fostering collaboration and continuous improvement. Strategic planning, process optimization, and organizational change leadership experience. Strong stakeholder engagement skills, with experience presenting to senior leadership and cross-functional teams. Proven expertise in governance, compliance oversight, and corrective action management. Advanced project management skills, including vendor oversight and multi-project coordination. Proven knowledge of design change evaluation, supplier quality assurance, and IT security assessment for third-party vendors. Proven experience leading audits, managing corrective action processes, and mentoring teams. Proven ability to work effectively with diverse teams across clinical, technical, and regulatory domains. Demonstrated ability to implement innovative solutions and leverage technology to improve auditing processes. Skilled in analyzing existing workflows, identifying inefficiencies, and introducing best practices that enhance accuracy and efficiency in audit execution.