Senior Supplier Quality Lead — GMP & Audits

Ardena; Franklin Township (NJ); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Flexible work

International environment

Professional development

Meaningful work

CARE culture

Job summary

Ardena, Somerset, NJ, is hiring a Senior Quality Specialist, Supplier Quality Management, to lead the site supplier quality program in a GMP environment. You will qualify and monitor suppliers, maintain quality agreements, and support audits, CAPA, and continuous improvement with cross-functional partners in QA, QC, Manufacturing, and Regulatory Compliance.

The role emphasizes risk-based supplier oversight, change notifications, and performance monitoring to ensure product quality and patient

Qualifications

• Bachelor’s degree in life sciences or related field; GMP experience preferred.
• 2–5 years in Quality Assurance, Quality Control, or Supplier Quality within GMP.
• Experience with supplier qualification, supplier audits, risk assessments, CAPA, deviation management, change control, and document control.
• Experience with regulatory inspections, client audits, internal audits, or supplier audits preferred.

Responsibilities

• Develop, implement, and maintain the Supplier Quality Management program for GMP manufacturing.
• Qualify, monitor, and maintain suppliers and quality documentation and quality agreements.
• Coordinate supplier onboarding, risk assessments, and supplier audits; review CAPA and corrective actions.
• Support investigations of supplier-related deviations and supplier performance monitoring.
• Prepare supplier quality metrics and participate in management reviews and inspections.

Skills

Quality Assurance

Supplier Quality

Documentation/Recordkeeping

Audit support

Regulatory compliance

MS Office

eQMS

ERP systems

Education

Bachelor’s degree in life sciences or related field

Tools

eQMS

ERP systems

Supplier management platforms

Microsoft Office

Job description

Ardena, Somerset, NJ, is hiring a Senior Quality Specialist, Supplier Quality Management, to lead the site supplier quality program in a GMP environment. You will qualify and monitor suppliers, maintain quality agreements, and support audits, CAPA, and continuous improvement with cross-functional partners in QA, QC, Manufacturing, and Regulatory Compliance.

The role emphasizes risk-based supplier oversight, change notifications, and performance monitoring to ensure product quality and patient