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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems, including ISO13485 and ISO15189, while effectively managing supplier quality programs and compliance with GCLP and GMP requirements. Proficient in project management and communication, ensuring alignment between business and compliance needs.
Highest-signal resume keywords
Quality Management System DevelopmentSupplier Quality Systems KnowledgeISO13485 and ISO15189 ComplianceProject Management SkillsBilingual Proficiency in French and English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality Data AnalysisDocument Control CoordinationSupplier AuditingSCAR System MaintenanceIT Vendor ManagementSoftware Development Lifecycle SupportPolicy and Procedure DevelopmentRisk ManagementVerification and ValidationChange Management
Soft Skills
Written and Verbal CommunicationCollaboration with Cross-Functional TeamsArticulation of Quality Agreements
Industry Keywords
GCLPGMPCAP/CLIACorporate Quality Management ReviewSupplier Corrective Action RequestQuality AgreementsAudit ExperienceCompliance RequirementsGlobal RegulationsQuality Procedures and Processes
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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