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Quality Operations & Execution:
- Implement and maintain quality systems aligned with regulatory requirements.
- Foster a culture of quality excellence and continuous improvement.
- Manage and mentor a lean quality team to optimize capabilities.
Quality Systems Management:
- Maintain and optimize the electronic Quality Management System (eQMS) in compliance with ISO 9001.
- Manage core QMS processes including document control, training, risk management, and audits.
- Track quality metrics, identify compliance trends, and execute proactive solutions.
Clinical Trial Quality:
- Provide quality oversight across clinical study development and operations.
- Collaborate with Clinical Operations to support protocol development and study oversight.
Software & Technology Quality:
- Review software development deliverables for audit-readiness and compliance.
- Maintain SDLC processes and tooling for in-house software development.
- Partner with Engineering teams to integrate quality controls early in development cycles.
N-Power Medicine
N-Power Medicine aims to reinvent drug development by transforming clinical trials through better integration with clinical practice. They are building a multi-disciplinary team with diverse expertise in healthcare, engineering, technology, and regulatory, sharing a core value of empowering community through generosity, curiosity, and humility.