npowermedicine - Clinical Quality Compliance Manager

• Quality Operations & Execution: • Implement and maintain best-in-class quality systems in alignment with N-Power’s quality strategy and regulatory requirements (e.g., FDA, ICH, 21 CFR Part 11, ISO 9001) • Foster a culture of quality excellence, compliance, and continuous improvement across the organization • Manage, mentor, and support the day-to-day-activities of a lean, high-performing quality team, optimizing capabilities, resources, and workflows in alignment with N-Power’s corporate goals and roadmap • Quality Systems Management: • Maintain, optimize, and serve as the primary administrator for the electronic Quality Management System (eQMS) in compliance with ISO 9001 and applicable regulatory requirements • Directly manage core QMS processes, including but not limited to document control, training management, risk management, internal and external audits, CAPA, nonconformances, change management, and supplier management. • Operationalize the eQMS to provide streamlined management of all Quality Management System functions, incorporating workflow enhancements and/or automations to support continuous improvement. • Track, analyze, and report on quality objectives and metrics, identify compliance trends and risks, and execute proactive, systematic solutions. • Serve as the lead executioner for the CAPA and nonconformance program, driving robust root-cause analysis and cross-functional remediation across clinical, technical, and corporate functions. • Coordinate the preparation, execution, and follow-up activities for internal, external, and customer audits to ensure ongoing audit-readiness. • Clinical Trial Quality: • Provide day-to-day quality oversight across N-Power’s clinical study development and operations to ensure GCP compliance throughout study planning, execution, and reporting. • Collaborate cross-functionally with Clinical Operations and Network Services teams to support clinical study protocol development, process development, operationalization, and study oversight. • Software & Technology Quality: • Review and approve software development release deliverables to ensure audit-readiness and adherence to compliance standards. • Execute and maintain the Software Development Life Cycle (SDLC) processes, infrastructure, and tooling for in-house software development, ensuring compliance with 21 CFR Part 11 and life sciences/FDA requirements. • Partner directly with Software Engineering and Technical Product teams to ensure quality and compliance controls are integrated smoothly into early development cycles. • Education, Experience, Behavioral Competencies, & Skills • BA or BS in a related field • 8+ years of progressive experience in Quality. • 2+ years of previous experience building and leading successful teams of quality professionals. • Exceptional collaboration, project management, and communication skills, with experience working with distributed teams. • Experience working in regulated healthcare, life sciences, or digital health companies. • Deep practical knowledge of regulatory frameworks including GCP, ISO 9001, and 21 CFR Part 11. • Hands-on experience administering, configuring, or significantly scaling an eQMS in a fast-growth or startup environment. • Deep experience managing clinical trial quality execution • A collaborative spirit, openness to differing perspectives, and a commitment to driving positive change in clinical research and patient care • Generous, Curious & Humble.