Senior Supplier Quality Associate — GxP & Compliance

Tonix Pharmaceuticals; North Dartmouth (MA); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Match

Paid Time Off

Job summary

Tonix Pharmaceuticals in the United States is seeking a Senior Associate, Supplier Quality to execute and oversee the supplier quality program supporting GxP operations and external contract organizations.

The role requires managing supplier qualifications, audits, change notifications, quality agreements, and continuous improvement across QA functions, ensuring FDA and global health authority standards are met.

Qualifications

• Bachelor’s degree in science or related discipline.
• Five+ years of Supplier Quality experience in biotech/pharma.
• Knowledge of global pharma regulations (FDA, EMA, cGMP) and GMP.
• GxP auditing and inspection experience preferred.
• Ability to travel up to 10%.
• Strong problem-solving, analytical, and communication skills.

Responsibilities

• Execute day-to-day operations of supplier quality assurance.
• Maintain the Approved Supplier List and audit docs.
• Lead GxP contractor and consultant qualification.
• Manage supplier quality agreements review/approval.
• Oversee Supplier Change Notification and CAPA processes.
• Provide compliance input to internal and external teams.
• Collect and monitor metrics for process control and improvements.
• Support internal audits and participate in regulatory inspections.
• Develop and implement GxP standards, policies, procedures.
• Execute supplier audits with the SQ team.
• Follow GMPs and SOPs; uphold safety and quality culture.
• Perform ad-hoc projects to support Tonix initiatives.

Skills

Problem solving

Analytical thinking

Regulatory knowledge

Team player

Planning & organization

Independent work

Communication skills

Travel readiness

Education

Bachelor’s degree in science or related field

Job description

Tonix Pharmaceuticals in the United States is seeking a Senior Associate, Supplier Quality to execute and oversee the supplier quality program supporting GxP operations and external contract organizations.

The role requires managing supplier qualifications, audits, change notifications, quality agreements, and continuous improvement across QA functions, ensuring FDA and global health authority standards are met.