Clinical Quality Consultant

4 days ago

Washington, Washington, D.C., United States Michelle Kusowski Consulting, LLC Full time

Company Description

Michelle Kusowski Consulting, LLC specializes in providing practical, scalable, and regulatory-aligned solutions for clinical quality management. The company offers expertise in areas such as GCP quality consulting, inspection readiness, vendor and CRO oversight, and risk-based quality management. Partnering with organizations, they provide clear, actionable recommendations, guidance during audits and inspections, and support for maintaining compliance without disrupting operational efficiencies. Their client-focused approach and flexible engagement models make them a trusted collaborator for companies of all sizes aiming for compliant and inspection-ready clinical trials.

Role Description

This part-time, temporary Clinical Quality Consultant (Specialist, Manager, or Director level) role is an remote based position as either an employee or independent contractor The Consultant will be provide Clinical Quality support and oversight of clinical development programs. Day to day activities will include leading and managing GCP related audits (site, vendor/CRO, internal, TMF) using a risk-based approach and may periodically conduct audits, providing guidance to study teams on quality issues and clinical study processes and systems, and performing quality reviews of clinical study documentation. Collaboration with cross-functional teams and maintaining operational momentum are key aspects of this role.

Qualifications

  • Strong skills in Clinical Quality Assurance with 5+ years of experience in the biotech/pharmaceutical industry
  • Knowledge of GCP guidelines and clinical trial standards is essential
  • Excellent interpersonal, communication, and collaboration skills for working in a team-focused, fast-paced environment
  • Bachelor's degree in life sciences, healthcare, or a related field is preferred
  • Ability to work independently and manage tasks within a flexible schedule.
  • Proficiency in common clinical and quality systems (eTMF, QMS, document management platforms)

Work Environment & Schedule

  • Flexible scheduling to accommodate variable weekly workloads
  • Remote work arrangement with periodic travel to clients, vendor, or clinical sites not to exceed 25%
  • Routine meetings will be scheduled within core business hours and with flexibility for non-meeting work.
  • To be eligible for consideration, candidates must reside in Washington State.
  • Applicants must be authorized to work in the United States at the time of application. We do not offer visa sponsorship and are not considering candidates with H-1B or F-1/OPT work authorization.

Compensation

  • Competitive hourly rate based on experience, estimated pay range $50-200/hr

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