Manager, Quality Management System, Supplier Quality

Posted 11 hours ago

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About the role

  • Quality systems manager leading QMS and supplier quality for CellCarta’s precision medicine laboratory services. Supporting audits, compliance, vendor management, and software lifecycle projects.

Responsibilities

  • Lead and support the development and sustainability of CellCarta’s Quality Management System
  • Harmonize quality procedures and processes
  • Provide quality data for the Corporate Quality Management Review
  • Develop and improve policies, procedures, and work instructions
  • Establish reports to gather and analyze quality data
  • Coordinate document control, including revisions, training assignments, and issuance of corporate procedures and policies
  • Support the Supplier Quality Program by classifying and qualifying suppliers
  • Audit suppliers and maintain quality agreements with corporate suppliers
  • Serve as the primary interface with corporate suppliers
  • Maintain the Supplier Corrective Action Request (SCAR) system
  • Maintain the global approved supplier list and audit schedule
  • Develop and execute an IT third-party vendor management program
  • Support software development projects throughout the software development lifecycle, including planning, requirements, risk management, design, verification, validation, release, and change management
  • Participate in ISO certification audits, including ISO-27001 and ISO13485
  • Serve as a subject matter expert on Quality Management Systems
  • Support proposal development while collaborating with cross-functional professionals

Requirements

  • Minimum bachelor’s degree in life sciences, applied sciences, business, or related field
  • Minimum of 5 years' industry or related experience
  • 2 years of audit experience
  • Knowledge and experience with supplier quality systems
  • Knowledge of GCLP and GMP requirements
  • Knowledge of ISO13485 and ISO15189 frameworks and CAP/CLIA requirements
  • Experience interfacing with suppliers and aligning on a quality agreement framework
  • Knowledge of compliance requirements for different stages of development and applicable global regulations
  • Proficiency in French and English, spoken and written
  • Demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity
  • Excellent project management skills
  • Ability to merge business and compliance needs to achieve effective solutions

Benefits

  • Competitive Wages
  • Vacation and Personal Days
  • Comprehensive Group Insurance Plans
  • RRSP Contribution with Employer Matching
  • Employee Annual Incentive Plan (EAIP)
  • Dialogue Telemedicine Service and Employee Assistance Program (EAP)
  • Referral Program
  • Career Advancement Opportunities
  • 100% remote work

Job title

Job type

Full Time

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

RemoteCanada

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