Manager, Quality Management System, Supplier Quality

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

📋 Description

• Oversee and assist in the creation and sustainability of CellCarta’s Quality Management System.

• Standardize quality procedures and processes.

• Supply quality data for the Corporate Quality Management Review.

• Formulate and enhance policies, procedures, and work instructions.

• Create reports to collect and analyze quality data.

• Manage document control, including updates, training assignments, and the distribution of corporate procedures and policies.

• Aid the Supplier Quality Program by assessing and qualifying suppliers.

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

• Act as the primary liaison with corporate suppliers.

• Oversee the Supplier Corrective Action Request (SCAR) system.

• Maintain the global approved supplier list and the audit schedule.

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

• Support software development initiatives throughout the software development lifecycle, including planning, requirements definition, risk management, design, verification, validation, release, and change management.

• Participate in ISO certification audits, such as ISO-27001 and ISO13485.

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

• Assist in 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 relevant experience.

• A minimum of 2 years of audit experience.

• Familiarity with supplier quality systems.

• Understanding of GCLP and GMP requirements.

• Knowledge of ISO13485 and ISO15189 frameworks and CAP/CLIA requirements.

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

• Awareness of compliance requirements for various development stages and applicable global regulations.

• Proficiency in both spoken and written French and English.

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

• Strong project management capabilities.

• Ability 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