Quality Systems & Supplier Quality Lead (Remote)

CellCarta; Northern (KY); Hybrid; USD 88,000 - 117,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401k retirement savings plan with a 건강

Vacation and sick time

Career development opportunities

Continuing education

Job summary

CellCarta in the United States is seeking a Manager, Quality Management System and Supplier Quality to lead and harmonize the QMS and supplier qualification efforts, supporting proposals and collaborating with a multidisciplinary team to advance human health.

The role oversees policy development, supplier audits, SCAR handling, and integration of ISO13485/ISO15189 and GMP requirements, with primary interface to corporate suppliers and global regulatory alignment.

Qualifications

• 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 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.

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.

Skills

Quality management systems

Auditing

Supplier quality

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree

Job description

CellCarta in the United States is seeking a Manager, Quality Management System and Supplier Quality to lead and harmonize the QMS and supplier qualification efforts, supporting proposals and collaborating with a multidisciplinary team to advance human health.

The role oversees policy development, supplier audits, SCAR handling, and integration of ISO13485/ISO15189 and GMP requirements, with primary interface to corporate suppliers and global regulatory alignment.