Clinical Quality Compliance Manager

N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how’ and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.

N-Power Medicine is hiring a Clinical Quality Compliance Manager. This position will be responsible for the day-to-day execution, maintenance, and continuous improvement of N-Power’s Quality Management System (QMS) and quality execution for N-Power clinical trials. This individual will play a hands-on role in ensuring compliance with regulatory standards, executing clinical trial quality oversight, and supporting quality by design in the development of regulated software and digital health solutions.

Role Objectives and Responsibilities

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.