Clinical Quality Compliance Manager

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N-Power Medicine, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

N-Power Medicine, Inc. is a company focused on transforming the drug development process within the oncology field through an innovative clinical trial platform. Their solutions aim to accelerate oncology drug development by providing comprehensive, standardized data collection, expert staffing support, and real-time analysis capabilities. N-Power Medicine partners with oncologists, biopharma companies, and patient advocacy groups to overcome the challenges of slow drug development, limited clinical trial access, and suboptimal real-world data. By leveraging their N-Power Platform, they aim to unlock critical insights from routine care data, improve clinical trial adoption, and empower oncology practices to become high-performing research centers.

📋 Description

• Implement and maintain best-in-class quality systems in alignment with N-Power’s quality strategy and regulatory requirements • 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 • Maintain, optimize, and serve as the primary administrator for the electronic Quality Management System (eQMS) • Directly manage core QMS processes including document control, training management, risk management, and internal and external audits • Coordinate the preparation, execution, and follow-up activities for internal, external, and customer audits

🎯 Requirements

• 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

🏖️ Benefits

• Equity at hire • Discretionary annual bonus based on company performance • Company benefits