Senior Manager, Supplier Quality and Quality Management Systems

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September 12

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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, fostering strategic partnerships and ensuring alignment with quality expectations. • Maintain and negotiate quality agreements. • Plan, execute, and oversee supplier audits, ensuring thorough documentation and follow-up. • Contribute to the development and implementation of a robust third-party IT vendor management program. • Maintain and enhance systems for managing supplier complaints and 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 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. • Partner with internal stakeholders to identify and implement process improvements that enhance quality system performance. • Manage and update corporate documents, including corporate supplier management materials, to present 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 is preferred. • Knowledge of GCLP, GMP, and global regulatory frameworks. • Proficiency in ISO 13485, ISO 15189, and CAP/CLIA requirements. • Lead supplier quality alignment initiatives, including development and negotiation of quality agreements. • Knowledge of compliance requirements for different stages of development and applicable global regulations. • Exceptional written and verbal communication skills. • Influence cross-functional teams; excellent project management skills. • Experience reviewing CSV documentation is preferred.

🏖️ Benefits

• Medical, dental, and vision benefits • 401k retirement savings plan with a healthy match • Vacation and sick time • Career development opportunities • Continuing education