Manager, Quality Management System, Supplier Quality

This is a fully remote position, open to applicants in Canada.

📋 Description

• Oversee and facilitate the development and sustainability of CellCarta's Quality Management System (QMS).

• Standardize quality procedures and processes.

• Supply quality data for the Corporate Quality Management Review.

• Create and enhance unified policies, procedures, and work instructions.

• Generate reports to collect and analyze quality data.

• Manage document control, including revisions, training assignments, and the issuance of corporate procedures and policies.

• Assist the Supplier Quality Program by classifying and qualifying suppliers.

• Conduct audits of suppliers and uphold quality agreements with corporate suppliers.

• Act as the primary liaison with corporate suppliers.

• Maintain the Supplier Corrective Action Request (SCAR) system, global approved supplier list, and audit schedule.

• Design and implement an IT third-party vendor management program.

• Aid software development projects throughout the software development lifecycle, encompassing planning, requirements, risk management, design, verification, validation, release, and change management.

• Engage in ISO certification audits, including ISO-27001 and ISO13485 audits.

• Function as a subject matter expert on Quality Management Systems.

• Support proposal development while collaborating with cross-functional teams.

⛳️ Requirements

• A minimum of a bachelor’s degree in life sciences, applied sciences, business, or a related discipline.

• At least 5 years of industry or related experience.

• 2 years of audit experience.

• Knowledge and experience with supplier quality systems.

• Familiarity with GCLP and GMP standards.

• Understanding of ISO13485 and ISO15189 frameworks as well as CAP/CLIA requirements.

• Experience in interfacing with suppliers and aligning on a quality agreement framework.

• Knowledge of compliance requirements for various development stages and relevant global regulations.

• Proficiency in both French and English, spoken and written.

• Proven written and verbal communication skills, including the ability to convey complex quality agreements clearly.

• Exceptional project management skills.

• Capability to integrate business and compliance needs to develop 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.