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 (QMS)
Harmonize quality procedures and processes
Provide quality data for the Corporate Quality Management Review
Develop and improve harmonized 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, 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 audits
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)
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