Manager, Quality Management System, Supplier Quality

Jobtailor; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

CellCarta is seeking a quality leadership professional to lead and sustain the Quality Management System (QMS) while harmonizing procedures and ensuring regulatory compliance across the organization.

The role includes coordinating supplier quality programs, audits, and quality data analysis for management reviews, alongside supporting software development lifecycle activities and ISO certifications.

Qualifications

• 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.

Responsibilities

• 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

Skills

Quality Management Systems

Audit Experience

Project Management

Written and Verbal Communication

Collaboration

Problem-Solving

Education

Bachelor's degree in Life Sciences or related field

Tools

SDLC

GCLP

ISO13485

ISO15189

CAP/CLIA

Supplier Quality Systems

Job 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.

Core Competencies

Demonstrates expertise in Quality Management Systems, including ISO13485 and ISO15189 frameworks, while effectively managing supplier quality systems and compliance with GCLP and GMP requirements. Proven ability to develop and harmonize quality procedures, support software development projects, and communicate complex quality agreements clearly.

Highest-signal resume keywords

• Quality Management System Development


• ISO13485 and ISO15189 Knowledge


• Supplier Quality Systems Experience


• Project Management Skills


• Audit Experience

ATS Optimization Keywords

Hard Skills

• Quality Data Analysis


• Document Control Coordination


• Supplier Corrective Action Requests (SCAR)


• Software Development Lifecycle (SDLC)


• Risk Management


• Verification and Validation


• Compliance Requirements Knowledge


• Policy and Procedure Development


• Harmonization of Quality Procedures


• Third-Party Vendor Management

Soft Skills

• Written and Verbal Communication


• Collaboration


• Problem-Solving

Industry Keywords

• GCLP


• GMP


• CAP/CLIA


• Supplier Quality Program


• Corporate Quality Management Review


• ISO Certification Audits


• Quality Agreement Framework


• Eastern Time Zone


• Life Sciences


• Applied Sciences