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.

This position is remote within the United States.

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. 

• 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.

  

Ability to travel may be required from time to time

 

The expected salary range for this position is $134,985 and $163,247. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits. 

More About Us:

We are a mission-driven, well-funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”

We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Covid-19 Policy –  The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine’s partners they serve. We reserve the right to modify or amend our corporate policy at any time.

Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas.