Manager, Quality Management System, Supplier Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and enhance the development and sustainability of CellCarta’s Quality Management System (QMS).

• Align quality procedures and processes for consistency.

• Supply quality data for the Corporate Quality Management Review.

• Assist in the development of proposals.

• Create and refine harmonized policies, procedures, and work instructions to fulfill site and business requirements while adhering to external regulations.

• Generate reports to collect and analyze quality data for the Corporate Management Review.

• Manage document control processes, including revisions, training assignments, and distribution of corporate procedures and policies.

• Contribute to the Supplier Quality Program by assessing and qualifying suppliers, conducting audits, maintaining quality agreements, acting as the primary liaison with corporate suppliers, managing SCAR systems, and overseeing the global approved supplier list and audit schedule.

• Design and implement a third-party vendor management program for IT.

• Support software development projects throughout the Software Development Life Cycle (SDLC), encompassing planning, requirements, risk management, design, verification, validation, release, and change management.

• Engage in ISO certification audits, including ISO-27001 and ISO13485.

• Act as a subject matter expert on Quality Management Systems.

⛳️ Requirements

• A minimum of a bachelor’s degree in life sciences, applied sciences, business, or a related field.

• At least 5 years of experience in the industry or a related field.

• A minimum of 2 years’ experience in auditing.

• Familiarity with supplier quality systems.

• Understanding of GCLP and GMP requirements.

• Knowledge of ISO13485 and ISO15189 frameworks as well as CAP/CLIA requirements.

• Experience in collaborating with suppliers and establishing a quality agreement framework.

• Ability to integrate business and compliance needs to develop effective solutions.

• Awareness of compliance requirements across various development stages and relevant global regulations.

• Proven written and verbal communication skills, with the ability to convey complex quality agreements clearly.

• Strong project management capabilities.

• Must be located in the U.S., preferably within the Eastern Time Zone.

🏝️ Benefits

• Medical, dental, and vision coverage.

• 401k retirement savings plan with a competitive match.

• Vacation and sick leave.

• Opportunities for career advancement.

• Continuing education support.