Manager, Quality Management System, Supplier Quality

CellCarta

. Lead and support the development and sustainability of CellCarta’s Quality Management System (QMS) .

Posted 9/25/2026full-timeRemote • United StatesMid-LevelSenior💰 $87,900 - $117,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and compliance with ISO standards, including ISO13485 and ISO15189. Proficient in supplier quality systems, project management, and effective communication of complex quality agreements.

Highest-signal resume keywords

Quality Management System DevelopmentSupplier Quality Program ManagementISO13485 ComplianceProject ManagementAudit Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Data AnalysisDocument ControlGCLP KnowledgeGMP KnowledgeCAP/CLIA RequirementsSDLC SupportRisk ManagementVerification and ValidationChange ManagementSupplier Classification

Soft Skills

Written CommunicationVerbal CommunicationProblem SolvingCollaborationClarity in Articulating Agreements

Tools & Technologies

SCAR SystemsQuality Management SoftwareDocument Management SystemsAudit Management ToolsVendor Management Systems

Industry Keywords

Life SciencesApplied SciencesBusiness ComplianceQuality AgreementsCorporate Quality Management ReviewSupplier AuditingGlobal Regulations

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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 assignments, and issuance of corporate procedures and policies
Support the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements, serving as primary interface with corporate suppliers, maintaining SCAR systems, 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 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

Requirements

What you’ll need

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

Benefits

Comp & perks

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