Senior Manager, Supplier Quality and Quality Management Systems

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September 10

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CellCarta

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Biotechnology • Healthcare Insurance • Pharmaceuticals

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.

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Lead the development and execution of supplier quality strategies, ensuring alignment with corporate quality objectives and regulatory requirements • Oversee supplier performance, risk management, and compliance • Lead comprehensive supplier assessments, including risk evaluations, audits, and qualification questionnaires • Serve as the primary interface with corporate suppliers and foster strategic partnerships • Maintain and negotiate quality agreements to reflect regulatory and operational requirements • Plan, execute, and oversee supplier audits, ensuring thorough documentation and follow-up • Contribute to development and implementation of a third-party IT vendor management program • Maintain and enhance systems for managing supplier complaints and Supplier Corrective Action Requests (SCARs) • Participate in ISO certification audits, including ISO 27001 and ISO 13485 • Serve as a subject matter expert on Quality Management Systems • Perform and support QA review of Computer System Validation (CSV) deliverables related to CellCarta systems • Collaborate across business units to develop harmonized policies, procedures, and work instructions • Lead initiatives to standardize key quality system SOPs and partner with stakeholders to implement process improvements • Manage and update corporate documents for presentation in management reviews

🎯 Requirements

• Minimum BA/BS in science or health-related discipline • Minimum of 5 years’ experience managing supplier quality systems • Specific experience in managing supplier quality and performing CSV reviews (preferred) • Two years of audit experience preferred • Knowledge of GCLP, GMP, and global regulatory frameworks • Proficiency in ISO 13485, ISO 15189, and CAP/CLIA requirements • Experience leading supplier quality alignment initiatives and negotiating quality agreements • Knowledge of compliance requirements for different stages of development and applicable global regulations • Exceptional written and verbal communication skills • Ability to influence cross-functional teams • Excellent project management skills • Experience reviewing CSV documentation preferred • Must be located in Canada (work authorization/location requirement)

🏖️ 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