Strategic Supplier Quality Leader

Ardena; New Jersey; On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Flexible working arrangements

Annual leave

Professional development

Job summary

Ardena, a Somerset, NJ based GMP-focused CDMO/CRO, seeks a Senior Quality Specialist, Supplier Quality Management to strengthen our supplier oversight. You will help qualify suppliers, monitor performance, and coordinate audits within a GMP framework, partnering with QA, Manufacturing, Regulatory, and Supply Chain to ensure product quality and patient safety.

The role emphasizes risk-based decision making, CAPA closure, and robust documentation practices to support continuous improvement across

Qualifications

• Bachelor's degree in life sciences or related field; GMP experience preferred.
• Experience in supplier qualification, audits, risk assessments, and CAPA.
• Familiarity with regulatory inspections and supplier quality systems.

Responsibilities

• Support supplier qualification and ongoing monitoring per procedures.
• Coordinate supplier audits and CAPA follow-up through closure.
• Review supplier quality documentation and risk assessments.
• Collaborate with QA, Manufacturing, and Supply Chain to ensure GMP compliance.

Skills

Quality Assurance

Supplier Quality

CAPA

Risk Assessment

Audits

Regulatory Inspections

Education

Bachelor's degree in life sciences or related field

Tools

eQMS

ERP systems

Document Management

Job description

Ardena, a Somerset, NJ based GMP-focused CDMO/CRO, seeks a Senior Quality Specialist, Supplier Quality Management to strengthen our supplier oversight. You will help qualify suppliers, monitor performance, and coordinate audits within a GMP framework, partnering with QA, Manufacturing, Regulatory, and Supply Chain to ensure product quality and patient safety.

The role emphasizes risk-based decision making, CAPA closure, and robust documentation practices to support continuous improvement across