Manager, Quality Management System, Supplier Quality

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $87.9k - $117.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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 • Support proposal development • Develop and improve harmonized policies, procedures, and work instructions to meet site and business needs and comply with external requirements • Establish reports to gather and analyze quality data for Corporate Management Review • Coordinate document control, including revisions, training assignment, and issuance of corporate procedures and policies • Support the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements, interfacing with corporate suppliers, maintaining Supplier Corrective Action Requests (SCAR), and maintaining the 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 (SDLC), including planning, requirements, risk management, design, verification, validation, release, and change management • Participate in ISO certification audits, including ISO-27001 and ISO13485 • Serve as a subject matter expert on Quality Management Systems • Collaborate with talented professionals dedicated to advancing human health

🎯 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 • Ability to merge business and compliance needs to achieve effective solutions • Knowledge of compliance requirements for different stages of development and applicable global regulations • Demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity • Excellent project management skills • Must be based in the U.S., ideally in the Eastern Time Zone • Legally authorized to work in the U.S.

🏖️ Benefits

• Medical, dental, and vision benefits • 401k retirement savings plan with a healthy match • Vacation and sick time • Career development opportunities • Continuing education • 100% remote work