Director, QA Operations: Strategy, Compliance & Supply Chain

Tonix Pharmaceuticals; Berkeley Heights, North Dartmouth (NJ, MA); On-site; USD 180,000 - 220,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

401k with company match and stock"

Paid Time Off and Holidays

Career Development and Training

Job summary

Tonix Pharmaceuticals seeks a Director of Quality Assurance Operations to lead Quality Operations for commercial and clinical manufacturing, distribution, and supply chain. You will partner with senior leadership to define and execute QA strategies, ensuring regulatory compliance and product quality across internal operations and external partners.

The role directs QA programs, manages budgets and teams, and serves as final quality authority on operational matters.

Qualifications

• B.S. degree preferably in a scientific discipline.
• Ten (10) years of Pharmaceutical/Biopharmaceutical industry experience with seven (7) years of Quality Assurance experience in US/EU environments preferred.
• Seven (7) years of direct supervisory experience with increasing responsibility over time preferred.
• Electronic Quality system applications (e.g., eDMS, QMS); Veeva Vault experience preferred.
• Experience participating in/hosting regulatory inspections and interacting with regulators preferred.
• Experience with commercial GxP processes including Good Distribution Practices and Drug Supply Chain Security Act (DSCSA).
• Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application.

Responsibilities

• Develop and implement the Quality Operations strategy to support commercial and development programs.
• Lead cross-functional teams to ensure quality, compliance readiness, and inspection readiness.
• Oversee quality operations across multiple functions and manage departmental performance against objectives.
• Set department goals, metrics, and resource plans aligned with business priorities.
• Escalate quality risks and drive corrective actions with stakeholders.
• Manage staffing, performance, compensation, and succession planning.
• Coordinate with contract QA organizations for timely issue resolution.
• Ensure QMS adherence and best practices in quality record generation and closure.
• Direct lot disposition decisions and related supply chain actions.
• Oversee APRs development/review and quality trend analysis.
• Ensure GDP and DSCSA compliance and labeling/packaging control.

Skills

Quality Assurance

Leadership

Regulatory inspections

Quality systems

GxP knowledge

Travel readiness

Education

B.S. degree preferably in a scientific discipline

Tools

eDMS

QMS

Veeva Vault

Job description

Tonix Pharmaceuticals seeks a Director of Quality Assurance Operations to lead Quality Operations for commercial and clinical manufacturing, distribution, and supply chain. You will partner with senior leadership to define and execute QA strategies, ensuring regulatory compliance and product quality across internal operations and external partners.

The role directs QA programs, manages budgets and teams, and serves as final quality authority on operational matters.