Senior Supplier Quality Specialist – GMP & Audits

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

Benefits offered by this job

Competitive salary

Tailored benefits package

Flexible working arrangements

International environment

Professional development

Meaningful work

Job summary

Ardena in Somerset, NJ, seeks a Senior Quality Specialist, Supplier Quality Management to lead the site program ensuring GMP supplier qualification, monitoring, and oversight across materials, services, and contract testing.

You will partner with QA, Manufacturing, Regulatory, and external suppliers to manage audits, CAPAs, risk assessments, change notifications, and continuous improvement, enabling compliant operations and patient safety.

Qualifications

• Bachelor's degree in life sciences, chemistry, biology, microbiology, engineering, pharmaceutical sciences, or a related technical discipline required; equivalent combination of education and relevant GMP experience may be considered.

Responsibilities

• Lead supplier qualification, monitoring, and risk assessments per procedures.
• Maintain supplier records, QA documentation, and quality agreements.
• Coordinate supplier audits and CAPA/tidying actions through closure.
• Support supplier change notifications and risk management processes.

Education

Bachelor's degree in life sciences, chemistry, biology, microbiology, engineering, pharmaceutical sciences, or a related technical discipline required; equivalent combination of education and relevant GMP experience may be considered

Tools

eQMS

ERP systems

supplier management platforms

Job description

Ardena in Somerset, NJ, seeks a Senior Quality Specialist, Supplier Quality Management to lead the site program ensuring GMP supplier qualification, monitoring, and oversight across materials, services, and contract testing.

You will partner with QA, Manufacturing, Regulatory, and external suppliers to manage audits, CAPAs, risk assessments, change notifications, and continuous improvement, enabling compliant operations and patient safety.