Manager, Quality Management System, Supplier Quality

Job not on LinkedIn

🔥 1 hour ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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CellCarta

WebsiteLinkedInAll Job Openings

501 - 1000 employees

📦 Logistics

💼 Consulting

🏥 Healthcare

Logistics • Consulting • Healthcare

CellCarta is a global contract research organization (CRO) specializing in precision medicine and biomarker development. The company offers a range of testing services, including clinical biomarkers, genomics, proteomics, and histopathology, to support therapeutic development across various fields such as oncology, immunology, and infectious diseases. CellCarta provides advanced technologies like flow cytometry, mass spectrometry, and digital pathology solutions, alongside comprehensive bioinformatics and biostatistics support. With expertise in integrated sample management and logistics, CellCarta partners with clients to navigate the complexities of drug development and ensure effective health solutions.

📋 Description

• 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) • Referral Program • Career Advancement Opportunities • 100% remote work