Job Summary
The Senior Associate, Supplier Quality performs activities for the Quality Assurance Supplier Quality function, including implementation and maintenance of Quality procedures/standards/systems related to GxP. Executes aspects of the supplier quality management program for materials/services supporting Tonix GxP operations and external contract organization activities.
Essential Functions
- Execute day-to-day supplier quality assurance operations
- Maintain the Approved Supplier List and supplier management files (incl. audit documentation)
- Execute GxP contractor/consultant qualification
- Review and approve supplier quality agreements
- Maintain Supplier Change Notification and Supplier Corrective Action Reporting processes
- Provide supplier quality compliance input to internal teams and external contract organizations
- Collect/monitor quality metrics and drive continuous improvement
- Maintain/support internal audit program and participate in regulatory inspections
- Develop/implement GxP quality standards, policies, and procedures
- Execute supplier audits as needed
- Follow OH&S procedures, GMPs, and SOPs; uphold company values
- Perform ad-hoc work/special projects
Necessary Skills and Abilities
- Troubleshooting/problem-solving; data analysis for regulatory compliance risk
- Knowledge of global pharma regulations (cGMPs, USP/other pharmacopeias, FDA guidance, 483s, Warning Letters, EIRs)
- GxP auditing/inspection experience preferred
- Collaborative, results-driven; strong planning/organization; independent with minimal supervision
- Excellent written/verbal communication; ability to travel up to 10%
Education/Experience
- Bachelorβs degree in science (or related) or equivalent experience (required)
- 5+ years Supplier Quality experience in biotech/pharma (required)
Compensation & Benefits
- Medical, dental, vision, life/AD&D, short/long-term disability, FSAs, HSA, EAP; pet insurance; 401k w/ match; paid time off/sick time/paid holidays; career development/training
- Salary range: $80,000β$110,000
Application Instructions
- Tonix does not offer sponsorship for this role.
- Tonix does not accept agency resumes unless contacted directly by internal Talent Acquisition; do not forward unsolicited resumes.