---
title: 'Director, Quality Assurance Operations at Tonix Pharmaceuticals'
canonical: 'https://feeny.ai/job/director-quality-assurance-operations-tonix-pharmaceuticals-berkeley-heights-nj-frckx0qmageg'
type: 'job'
last_seen: '2026-10-28'
---

# Director, Quality Assurance Operations at Tonix Pharmaceuticals 

- **Company:** Tonix Pharmaceuticals 
- **Location:** Berkeley Heights NJ OR North Dartmouth, MA
- **Compensation:** $180k–$220k
- **Posted:** 2026-10-26
- **Last confirmed live:** 2026-10-28
- **Apply:** https://job-boards.greenhouse.io/tonixpharmaceuticals/jobs/4467322009

## Job description

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 [www.tonixpharma.com](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D9p5FBvlzG2u-9NzVEDdUgRNdl57Mw08p4h9XviYYnbwVJ-X_DNEOeN4RdGA64IhTnk9R4lQWNXhq0g8TrvoRTCZSpqmowBapMZCbqP_sxm0%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987080441%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=WrmW8ZuY9XRYJZM0BMPu3thoab5uVHnt9SqBNHIoDuU%3D&reserved=0) and follow the Company on [LinkedIn](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbldblPUeLBo2VtrimIDsthVk4RaPH1sCjnDw18J2Q9UGKOYpi7kKsd6NuJ4rb7a1ocGevguAt4l_8t8TE5rfCP1YmSBTJO1HR9Uo9KAv_DEwtbEkJhm1CdLRAEbAUNB-&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987109283%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dHRzyv5dfKFOhCroh809txjNcJOjNrBSQRyfSgHaIu8%3D&reserved=0) and [X](https://nam10.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0NgIEJjy96AytWlfgCqgqVv5cOeUVkGOTFS78koSy22XXOczOtXjxSorNUcN-uDTk4CYVQkJndgCk6o2RQBlKQ%3D%3D&data=05%7C02%7Cmarsha.ihrig%40tonixpharma.com%7C016ba434378242bb501908dea48d8908%7C9f3c9f8851ca4393815e405a5f206a29%7C0%7C0%7C639129124987130654%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=frLcoK5ETOWzJq9lmvkirCS8HaHc2WCX%2Fg4ESMSdLgk%3D&reserved=0).

*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 SymTouch 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.

Position Overview

The Director of Quality Assurance Operations provides strategic leadership and oversight for Quality Assurance activities supporting commercial and clinical manufacturing, distribution, and supply chain operations. As a senior member of the Quality leadership team, this role partners with management to develop and execute quality operations and compliance strategies that support corporate objectives, regulatory requirements, and business growth.

The Director maintains accountability for the effectiveness of Quality Operations programs, directs departmental activities through staff, and serves as the final Quality decision-maker for assigned operational quality matters. The position is accountable for departmental budget management, resource planning, organizational effectiveness, and quality compliance outcomes across internal operations and external business partners.

## Key Responsibilities

- Develop and execute the Quality Operations strategy in partnership with senior leadership to support commercial and development programs.
- Participate with senior management in establishing long-term quality, compliance, inspection readiness, and operational objectives.
- Direct quality operations activities across multiple functional areas. Accountable for overall departmental performance and achievement of strategic objectives.
- Establish department goals, performance metrics, and resource plans aligned with organizational priorities and business objectives.
- Identify, evaluate and communicate product quality and compliance risks and drive mitigation strategies. Serve as the final Quality authority for operational quality decisions impacting assigned products, processes and compliance programs. Make final decisions regarding quality risk assessments, compliance remediation plans and escalation actions.
- Lead a multi-level Quality organization and develop Quality Assurance Operations personnel. Exercise authority for hiring, performance management, compensation recommendations, promotions, succession planning, disciplinary actions, and terminations.
- Approve staffing plans and workforce allocations. Allocate departmental resources to achieve business and compliance objectives. Provide strategic leadership for departmental organization design and resource planning.
- Establish strong relationships with contract Quality organizations to ensure timely resolution of quality issues
- Partner with the internal project teams to ensure adherence to Quality Management System (QMS) requirements and drive best practices in quality record generation and closure
- Direct lot disposition activities in support of commercial and clinical supply demands. Serve as the Quality approver for product disposition decisions and quality-related supply chain actions.
- Support the development, and review of Annual Product Reviews (APRs), contributing quality-related content and advising on improvements based on identified trends, findings, and risks.
- Oversee GDP and DSCSA compliance activities to ensure compliant distribution, product traceability, and supply chain security
- Oversee artwork management processes to ensure compliant control, approval, and implementation of labeling and packaging materials
- Manage third-party audits and participate in internal audits as well as regulatory inspections
- Review regulatory submission documentation related to NDAs, BLAs, INDs, information requests and annual reports
- Analyze, report, and present metrics to functional teams and Quality management; Identify any risks and recommend any required actions and monitor implementation of mitigation or preventive actions
- Author, review, and/or approve internal policies, procedures and quality documentation
- Develop, manage and maintain accountability for the Quality Operations budget. Approve departmental expenditures and resource allocations. Monitor financial performance and implement corrective actions to achieve budget objectives. Provide budget forecasts and investment recommendations to senior leadership.

## 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
- Direct experience managing Quality System activities within regulated pharmaceutical or biotechnology environments
- Knowledge of the drug development and commercialization process
- Proficiency with Quality system applications (e.g.,eDMS, QMS)
- Comprehension of appropriate escalation regarding Quality as well as product and/or patient safety issues
- Excellent written and verbal communication skills
- Strong planning and organizational skills
- Dedicated team player who can withstand the high demands of a fast-paced environment
- Comfortable working independently with minimal supervision
- Results driven, problem solver, and collaborator
- Demonstrated ability to perform the essential duties of the position with or without accommodation
- Ability for travel up to 20% of the time

Salary Range $180,000—$220,000 USD

*Please note that Tonix does not offer sponsorship for this role.

Recruitment & Staffing Agencies

Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes.

## Compensation & Benefits

Tonix provides a comprehensive compensation and benefits package which includes:

- Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs
- Pet Insurance
- Retirement Savings 401k with company match and annual discretionary stock options
- Generous Paid Time Off, Sick Time, & Paid Holidays
- Career Development and Training

Tonix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, genetics, or any other characteristic protected by law.  In addition to federal law requirements, Tonix complies with applicable state and local laws governing nondiscrimination in employment.  This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.  Tonix expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic, information, disability, veteran status, or any other characteristic protected by law.

## About Tonix Pharmaceuticals 

## Company Overview
- **One-liner**: A fully-integrated biopharmaceutical company commercializing and developing innovative therapies for central nervous system disorders, immunology, infectious diseases, and rare diseases.
- **Entity Type**: Public (NASDAQ: TNXP)
- **Headquarters**: Berkeley Heights, New Jersey, United States (as indicated by zip code 07922 on the investor relations page) [ir.tonixpharma.com](https://ir.tonixpharma.com/)
- **Founded**: Not publicly available from provided sources
- **Founders**: Not publicly available from provided sources

## Core Business
- **Primary industry/industries**: Biotechnology / Pharmaceuticals (therapeutics)
- **Target customers**: B2B – physicians (rheumatology, primary care, pain management, neurology), hospitals, specialty distributors, and patients through prescription-based access.
- **Mission or purpose statement**: “We listen, we develop, we deliver – so that patients feel seen, heard, and empowered to live fully again.” [tonixpharma.com](https://www.tonixpharma.com/)

## Products & Services
- **TONMYA® (cyclobenzaprine HCl sublingual tablets)**: Approved in the U.S. (August 2025) and launched in November 2025 for the treatment of fibromyalgia in adults – the first new medicine for fibromyalgia in over 15 years. Non-opioid, centrally acting analgesic designed for bedtime dosing. [tonixpharma.com](https://www.tonixpharma.com/)
- **Zembrace® SymTouch® (sumatriptan injection)**: FDA-approved prescription product for the treatment of acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **Tosymra® (sumatriptan nasal spray)**: FDA-approved prescription product for acute migraine. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-102 SL (cyclobenzaprine HCl sublingual tablets)**: Investigational for Major Depressive Disorder (Phase 2 planned mid-2026) and Acute Stress Disorder/Reaction (Phase 2 enrolling, OASIS study at UNC funded by DoD). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-4800 (anti-OspA monoclonal antibody)**: Seasonal prevention of Lyme disease – Phase 2 field study planned first half 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-1500 (humanized anti-CD40L mAb)**: Phase 2-ready for prevention of kidney transplant rejection (investigator-initiated study expected mid-2026) and treatment of autoimmune diseases. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-1300 (double-mutant cocaine esterase)**: Phase 2 for cocaine intoxication; FDA Breakthrough Therapy designation. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-2900 (intranasal oxytocin + magnesium)**: For Prader-Willi Syndrome – Orphan Drug and Rare Pediatric Disease designations; Phase 2 planned Q1 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-801 (horsepox live virus vaccine)**: Preclinical – mpox/smallpox protection; Phase 1 expected in 2027. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-4200 (small molecule anti-CD45)**: Broad-spectrum antiviral for biodefense; preclinical, supported by up to $34M DoD contract. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-1700 (TFF2-albumin fusion)**: Preclinical for gastric/colorectal cancer in combination with PD-1 blockade (in-licensed from Columbia University). [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)
- **TNX-4900 (Sigma-1 receptor antagonist)**: Preclinical non-opioid analgesic for neuropathic pain. [10-K](https://ir.tonixpharma.com/sec-filings/all-sec-filings/content/0001999371-26-005730/0001999371-26-005730.pdf)

## Market Standing
- **Valuation/Market Cap**: Not publicly available from provided sources (public stock; market cap fluctuates)
- **Key Metric**: Annual Revenue – Not disclosed in provided sources (commercial launch of TONMYA began November 2025; earlier revenue from Zembrace/Tosymra). Total funding rounds not applicable for public company. R&D expenditures detailed in 10-K but not extracted.
- **Notable Investors/Partners**: Almac Pharma Services (commercial supply for TONMYA) [10-K]; U.S. Department of Defense (DTRA contract up to $34M for TNX-4200) [10-K]; University of North Carolina (OASIS study for TNX-102 SL) [10-K]; Columbia University (TNX-1700 in-license) [10-K].
- **Growth Signals**: First FDA approval and launch of internally developed drug TONMYA (Nov 2025); expanding commercial payer coverage (second commercial agreement covering ~52M U.S. lives) [tonixpharma.com]; multiple Phase 2 programs advancing; ownership of two manufacturing facilities (RDC in Frederick, MD and ADC in Dartmouth, MA) [10-K].

## Competitive Advantages
- **First-mover in fibromyalgia**: TONMYA is the first new FDA-approved treatment for fibromyalgia in 15+ years, with a proprietary sublingual formulation that offers differentiated bioavailability and tolerability.
- **Broad, diversified pipeline**: Covers CNS, immunology, infectious disease, and rare disease – reducing single-program risk and providing multiple shots on goal.
- **In-house manufacturing**: Owned R&D Center (Frederick, MD) with BSL-2/3 capability and an Advanced Development Center (Dartmouth, MA) for live-virus vaccine and biologics production (currently decommissioned but ready for reactivation) [10-K].
- **Non-opioid focus**: All analgesic candidates (TONMYA, TNX-4900) are non-opioid, aligning with regulatory and societal trends away from opioids.
- **Government partnerships**: DTRA contract for biodefense work (TNX-4200) provides non-dilutive funding and mission relevance.

## Strategic Focus
- **Grow TONMYA**: Expand commercial coverage, physician adoption, and patient access for fibromyalgia treatment.
- **Advance pipeline**: Initiate or complete Phase 2 studies for TNX-102 SL (MDD, ASD), TNX-4800 (Lyme), TNX-1500 (transplant rejection), TNX-1300 (cocaine intoxication), TNX-2900 (Prader-Willi), and move TNX-801 (mpox/smallpox vaccine) into Phase 1.
- **Pursue strategic business development**: In-licensing, partnerships, and potential acquisitions to augment pipeline and commercial portfolio [10-K].

## Why Work Here
- **Culture**: The company emphasizes a collaborative, inclusive environment where every voice is heard. Mission-driven focus on “listening to patients’ lived experiences” and developing therapies for underserved, complex conditions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/)
- **Work model**: Information on remote/hybrid policy not publicly available. Office and lab facilities in Berkeley Heights, NJ (HQ), Frederick, MD (R&D Center), and Dartmouth, MA (Advanced Development Center).
- **Team & growth**: Opportunity to work on first-in-class drug launches (TONMYA) and cutting-edge science across multiple therapeutic areas. The company is at a pivotal stage transitioning from pure R&D to a commercial organization, offering varied career pathways.
- **Benefits**: Equal opportunity employer; does not offer visa sponsorship for open positions. [tonixpharma.com/careers](https://www.tonixpharma.com/careers/)
- **Notable perks/engineering culture**: Not detailed, but the science-driven environment with in-house manufacturing and government-funded biodefense work may appeal to researchers and engineers in pharma.

## Sources
1. [tonixpharma.com](https://www.tonixpharma.com/) – Company homepage, mission, product info, lat

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