Manager, Quality Management System, Supplier Quality

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

📋 Description

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

• Align quality procedures and processes across the organization.

• 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 address site and business requirements while ensuring compliance with external regulations.

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

• Manage document control, which includes revisions, training assignments, and distribution of corporate procedures and policies.

• Assist the Supplier Quality Program by categorizing and qualifying suppliers, conducting audits, maintaining quality agreements, collaborating with corporate suppliers, managing Supplier Corrective Action Requests (SCAR), and overseeing the global approved supplier list and audit schedule.

• Develop and implement an IT third-party vendor management program.

• Support software development initiatives throughout the software development lifecycle (SDLC), which encompasses planning, requirements gathering, 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.

• Collaborate with skilled professionals committed to enhancing human health.

⛳️ 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 area.

• A minimum of 2 years of auditing experience.

• Familiarity with supplier quality systems.

• Understanding of GCLP and GMP regulations.

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

• Experience in engaging with suppliers and aligning on quality agreement frameworks.

• Capability to integrate business and compliance requirements to develop effective solutions.

• Awareness of compliance obligations for various development stages and relevant global regulations.

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

• Strong project management capabilities.

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

• Legally authorized to work in the U.S.

🏝️ Benefits

• Medical, dental, and vision coverage.

• 401k retirement savings plan with a generous match.

• Paid vacation and sick leave.

• Opportunities for career development.

• Continuing education support.

• Fully remote work environment.