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Clinical Quality Compliance Manager
N-Power Medicine, Inc.Clinical Quality Compliance Manager overseeing quality compliance in clinical trials for N-Power Medicine. Responsible for maintaining quality management systems and ensuring regulatory compliance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in implementing and maintaining Quality Management Systems (QMS) in regulated environments, with a strong focus on compliance, continuous improvement, and team leadership. Proven ability to manage core QMS processes and foster a culture of quality excellence within healthcare and life sciences sectors.
Highest-signal resume keywords
Quality Management System (QMS)Regulatory Frameworks (GCP, ISO 9001, 21 CFR Part 11)Team Leadership and MentoringElectronic Quality Management System (eQMS)Clinical Trial Quality Execution
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Management System (QMS)Regulatory FrameworksDocument ControlTraining ManagementRisk ManagementInternal AuditsExternal AuditsClinical Trial Quality ExecutionEQMS AdministrationQuality Compliance
Soft Skills
CollaborationProject ManagementCommunicationMentoringContinuous Improvement
Tools & Technologies
Electronic Quality Management System (eQMS)
Industry Keywords
HealthcareLife SciencesDigital HealthRegulatory ComplianceQuality Excellence
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Equity at hire
- Discretionary annual bonus based on company performance
- Company benefits