Praxis

Quality Systems Manager

Praxis

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $124,000 - $144,000 per year

About the role

  • Design, implement, and maintain company-wide stage-appropriate Quality Systems aligned with GxP principles.
  • Regularly assess and enhance GxP practices to meet evolving regulations.
  • Collaborate with cross-functional teams to drive GxP excellence.
  • Provide training on GxP requirements to personnel at all levels.
  • Provide coaching on Quality best practices and procedures.
  • Support implementation and training on new quality processes.
  • Conduct compliance risk assessments and trend analysis.
  • Support oversight of the Supplier Quality Management program, Training, and Document Control.
  • Ensure adequate/approved suppliers and vendors are utilized by the company.
  • Establish, compile, track, and present Quality Metrics for Quality Management Review.
  • Provide input into decisions for change management and CAPA programs.
  • Support inspection readiness activities, including participation in audits.

Requirements

  • Bachelor’s degree in life sciences, engineering, or related field (preferably Chemistry or Biology) or equivalent experience.
  • 5–7 years of relevant quality experience, including GxP quality systems in the pharmaceutical or biotech industry.
  • Experience in Electronic Document Management Systems (EDMS) and Quality Management Systems (QMS); familiarity with Veeva preferred.
  • Experience in quality systems and/or quality operations.
  • Strong knowledge of global regulations, particularly from the EU and US.
  • Strong understanding of GxPs, especially GMP.
  • Proficiency in Microsoft Office, especially Excel, PowerPoint, and Word.
  • Experience working in a pharmaceutical GMP environment.
  • Physical and mental requirements include regular use of a computer and devices, clear communication, and movement.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits.
  • Voluntary plans to personalize coverage.
  • 401(k) matching dollar-for-dollar up to 6% on eligible contributions.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Flexible wellness benefit.
  • Generous PTO.
  • Paid holidays and company-wide shutdowns.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GxP principlesQuality Systemscompliance risk assessmentstrend analysisSupplier Quality ManagementQuality Metricschange managementCAPA programsElectronic Document Management Systems (EDMS)Quality Management Systems (QMS)
Soft Skills
collaborationtrainingcoachingcommunicationorganizational skills