Manager, Quality Management System and Supplier Quality

Manager, Quality Management System and Supplier Quality (Remote)

Are you looking to take the next step in your career? CellCarta , a Contract Research Organization, is seeking a Manager, Quality Management System and Supplier Quality to join our dynamic team. In this role, you will support proposal development while collaborating with talented professionals dedicated to advancing human health. Apply today and take the first step toward an exciting career with CellCarta !

Summary

The Manager of Quality Management System and Supplier Quality is responsible for leading and supporting the development and sustainability of the Quality Management System (QMS) at CellCarta by harmonizing quality procedures and processes and providing quality data for the Corporate Quality Management Review. This position serves as a leading in classifying and qualifying suppliers used by CellCarta .

Responsibilities
- Aid in the development and improvement of harmonized policies, procedures, work instructions to meet site and business needs and to comply with external requirements.

- Establish reports to gather and analyze quality data as an input into Corporate Management Review.

- Aid in the coordination of document control, including revisions, training assignment, and issuance of corporate procedures and policies.

- Supports the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements with corporate suppliers, serving as a primary interface with corporate suppliers, maintaining a system for Supplier Corrective Action Requests (SCAR), and maintaining the global approved supplier list and audit schedule.

- Aid in the development and execution of an IT third party vendor management program.

- Acts as key team member for software development projects, providing support throughout the software development lifecycle (SDLC), including planning, requirements, risk management, design, verification, validation, release, and change management.

- Participate with ISO certification audits, ISO-27001, ISO13485. Serve as a subject matter expert on Quality Management Systems.

Education - Minimum bachelor’s degree in life sciences, applied sciences, business, or related field

Main Requirements

- Minimum of 5 years' industry or related experience, 2 years of audit experience

- Knowledge and experience with supplier quality systems GCLP and GMP requirements.

- Knowledge of ISO13485, ISO15189 framework 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, must have knowledge of applicable global regulations.

- Must have demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.

- Excellent project management skills.

Working Conditions

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Working hours: Monday to Friday, 9:00 AM to 5:00 PM, with 100% remote work.

- Must be based in the U.S., ideally in the Eastern Time Zone

What We Can Offer

- Competitive wages: $87,900 to $117,200

- Medical, dental, and vision benefits

- 401k retirement savings plan with a healthy match

- Vacation and sick time

- Career development opportunities

- Continuing education

About CellCarta

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.

Joining CellCarta means working with dedicated professionals who are focused on achiev