Senior Associate, Supplier Quality North Dartmouth, MA or Berkeley Height, NJ

Tonix Pharmaceuticals
* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg).

Tonix is investigating TONMYA® in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia

OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. In addition, the Company is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit  and follow the Company onLinked

In andX .

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace Sym Touch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Job Summary

The Senior Associate, Supplier Quality performs activities for the Quality Assurance Supplier Quality function. The individual in this position performs duties associated with the implementation and maintenance of Quality procedures, standards and systems related to GxP activities. The individual in this position executes aspects of the supplier quality management program that provides materials and services to Tonix for GxP operations as well as external contract organization activities.

The individual in this position works with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements. The individual in this position also is directly involved in the execution of QA strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to GxP activities and to ensure a culture of quality and compliance.

Essential Functions

• Execute day-to-day operations of supplier quality assurance
• Maintain the Approved Supplier List and supplier management files including audit documentation
• Execute GxP contractor and consultant qualification process
• Manage supplier quality agreement review and approval
• Maintain the Supplier Change Notification and Supplier Corrective Action Reporting processes to ensure supplier adherence to Tonix requirements
• Provide compliance input for internal teams as well as external contract organizations related to supplier quality
• Collect and monitor metrics to ensure control of systems and drive continuous improvements
• Maintain and support the internal audit program as well as participate in regulatory inspections
• Develop and implement GxP quality standards, policies, and procedures
• Execute supplier audits with the supplier quality team, as needed.
• Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s)
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
• Perform ad-hoc work/special projects as necessary to support Tonix on various business initiatives

Necessary

Skills and Abilities

• Demonstrated troubleshooting and problem-solving skills
• Ability to analyze a wide variety of information and data to support decisions regarding potential risks associated with regulatory compliance
• Knowledge of global pharmaceutical industry regulations, standards, and guidelines, such as, cGMPs (FDA, EMA), USP and other Pharmacopeia, FDA Guidance, 483s, Warning Letters, EIRs etc.
• GxP auditing and inspection experience preferred
• Collaborative, results-driven team player who excels in a dynamic environment
• Dedicated team player who can withstand the high demands of a fast-paced environment
• Strong planning and organizational skills
• Comfortable working independently with minimal supervision
• Highly organized, results driven, problem solver, and collaborator
• Excellent organizational, written, and verbal communication skills
• Demonstrated ability to perform the essential duties of the position with or without accommodation
• Ability to travel up to 10%

Educational Requirements

• Bachelor’s degree in science or other related discipline or equivalent work experience required

Experience Requirements

• Five (5) plus years of Supplier Quality related experience in the…