Clinical Quality Compliance Manager

1 month, 1 week ago
Full-time
Lead
Quality Assurance and Testing
N-Power Medicine

N-Power Medicine

N-Power Medicine accelerates drug development by creating a research-ready network that integrates standard of care patients and diverse populations into clinical trials, facilitating informed decision-making for phase II to phase III studies in oncology.

Biotechnology
11-50
Founded 2021

Description

  • Implement and maintain the company’s quality management system in alignment with quality strategy and regulatory requirements.
  • Foster a culture of quality excellence, compliance, and continuous improvement across the organization.
  • Manage, mentor, and support a lean quality team while optimizing capabilities, resources, and workflows.
  • Serve as the primary administrator for the electronic Quality Management System (eQMS).
  • Own core QMS processes including document control, training management, risk management, audits, CAPA, nonconformances, change management, and supplier management.
  • Operationalize the eQMS with workflow enhancements and automations to improve quality system efficiency.
  • Track, analyze, and report quality objectives and metrics, and drive proactive solutions to compliance trends and risks.
  • Lead the CAPA and nonconformance program, including root-cause analysis and cross-functional remediation.
  • Provide day-to-day quality oversight for clinical study development and operations to ensure GCP compliance.
  • Collaborate with Clinical Operations, Network Services, Software Engineering, and Technical Product teams on study development, process development, and quality/compliance integration.

Requirements

  • BA or BS in a related field.
  • 8+ years of progressive experience in Quality.
  • 2+ years of experience building and leading teams of quality professionals.
  • Experience working with distributed teams.
  • Experience in regulated healthcare, life sciences, or digital health companies.
  • Deep practical knowledge of 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.
  • Exceptional collaboration, project management, and communication skills.
  • Applicants must be currently authorized to work in the U.S. on a full-time basis, and the company will not sponsor work visas.

Benefits

  • Remote position within the United States.
  • Expected salary range of $134,985 to $163,247.
  • Equity at hire.
  • Discretionary annual bonus based on company performance.
  • Eligible for company benefits.
  • Highly attractive compensation package.
  • Balanced and flexible work environment.
  • Competitive industry benefits, including a 401(k) plan and other company perks.

Interested in this position?

Apply directly on the company website

Apply Now

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