Quality Management & Supplier Quality Lead (Remote)

Caprion Biosciences Inc.; Naperville (IL); Remote; USD 88,000 - 117,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401k retirement savings with match

Paid vacation and sick leave

Career development opportunities

Continuing education

Job summary

CellCarta Biosciences Inc. is seeking a Manager of Quality Management System and Supplier Quality to lead and harmonize the QMS and supplier quality program, with a remote work option.

The role includes developing harmonized policies, establishing quality data reports for Corporate Management Review, coordinating document control, and supporting supplier qualification, supplier audits, and SCAR processes. It also covers IT vendor management and SDLC quality activities, plus ISO audits.

Qualifications

• Bachelor's degree in life sciences, applied sciences, business, or related field.
• 5+ years of industry experience with 2 years of audit experience.
• Knowledge of supplier quality systems, GCLP and GMP.
• Knowledge of ISO13485 and CAP/CLIA requirements.
• Experience interfacing with suppliers and quality agreements.
• Strong written and verbal communication; ability to articulate complex quality agreements.
• Excellent project management skills.

Responsibilities

• Harmonize QMS policies, procedures, and work instructions.
• Establish reports to analyze quality data for Corporate Management Review.
• Coordinate document control including revisions and training.
• Support Supplier Quality Program: classify/qualify suppliers, audits, quality agreements, SCAR system, global supplier list and audit schedule.
• Develop and execute IT third party vendor management program.
• Provide SDLC support for software development projects.
• Participate in ISO audits (ISO 27001, ISO 13485) and serve as SME on QMS.

Skills

Quality management systems

Supplier quality

Audit

ISO 13485

Regulatory compliance

SDLC support

Project management

Documentation control

Education

Bachelor's degree in life sciences, applied sciences, business

Tools

Quality management software

SCAR management system

Supplier quality systems

Job description

CellCarta Biosciences Inc. is seeking a Manager of Quality Management System and Supplier Quality to lead and harmonize the QMS and supplier quality program, with a remote work option.

The role includes developing harmonized policies, establishing quality data reports for Corporate Management Review, coordinating document control, and supporting supplier qualification, supplier audits, and SCAR processes. It also covers IT vendor management and SDLC quality activities, plus ISO audits.