Senior Supplier Quality Specialist — GxP & Compliance

Tonix Pharmaceuticals; Berkeley Heights (NJ); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401k with company match

Paid Time Off

Job summary

Tonix Pharmaceuticals is seeking a Senior Associate, Supplier Quality to support the QA supplier quality function, implementing and maintaining GxP procedures for materials and services supplied to Tonix.

This role focuses on executing supplier QA activities, managing supplier audits, change notifications, and QA metrics, while ensuring compliance with FDA/global guidelines; travel up to 10% is expected.

Qualifications

• Bachelor’s degree in science or related discipline or equivalent work experience.
• 5+ years of Supplier Quality experience in biotech/pharma.
• Knowledge of global regulations (cGMP, FDA, EMA, USP).
• GxP auditing/inspection experience preferred.
• Willing to travel up to 10%.
• Collaborative, results-driven team player in a fast-paced environment.
• Strong planning and organizational skills, written and verbal communication.

Responsibilities

• Execute day-to-day supplier quality assurance operations.
• Maintain Approved Supplier List and audit documentation.
• Lead GxP contractor/consultant qualification processes.
• Manage supplier quality agreements review/approval.
• Oversee Change Notification and Corrective Action processes.
• Provide compliance input to internal and external teams.
• Collect and monitor metrics; drive continuous improvement.
• Support internal audits and regulatory inspections.

Skills

Troubleshooting

Problem solving

Regulatory knowledge

GxP auditing

Team player

Independent worker

Planning & organizing

Communication

Attention to detail

Travel readiness

Risk assessment

Education

Bachelor’s degree in science or related discipline

Job description

Tonix Pharmaceuticals is seeking a Senior Associate, Supplier Quality to support the QA supplier quality function, implementing and maintaining GxP procedures for materials and services supplied to Tonix.

This role focuses on executing supplier QA activities, managing supplier audits, change notifications, and QA metrics, while ensuring compliance with FDA/global guidelines; travel up to 10% is expected.