Director, Clinical and Nonclinical Quality Assurance - Berkeley Heights - Tonix Pharmaceuticals

Description

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.

Tonix's development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader‑Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.

Tonix owns and operates a state‑of‑the‑art infectious disease research facility in Frederick, Md.

Please visit for specifics on the pipeline.

*All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.

The Director, Clinical & Non‑Clinical Quality Assurance, situated within the Quality Assurance department, will provide quality oversight and support across all GCP, GLP, IND Enabling, and bioanalytical studies and programs.

This role will partner strategically with Clinical Operations and Nonclinical functions to establish and maintain pragmatic, risk‑based quality frameworks that ensure regulatory compliance, safety and data integrity from early development through clinical execution.

This position will be responsible for ensuring adherence to GCP, GcLP, and GLP regulations and developing a quality oversight model for preclinical study management. This position will oversee audit professionals/consultants with principal responsibility for quality oversight of regulated study activities.

This position will collaborate cross‑functionally as an advocate for quality standards and in this role will explain these quality standards to the other functions and thus should be viewed by other functions as an SME and advisor on meeting these quality standards.

support activities both internally and at Tonix contracted organizations including but not limited to regulatory inspections, third‑party audits, risk assessments, deviations, CAPAs, and change controls.

The Director, Clinical & Non‑Clinical Quality Assurance, will lead, direct, and advise continuous improvement of the department's area of control, and assist in any other area as needed or directed by management.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Evolve and deliver the clinical and nonclinical quality strategy, embedding regulatory, ICH (e.g., E6 & M3), and OECD principles throughout the development lifecycle.
• Maintain and advance the appropriate Quality Management System (QMS) for GCP, GcLP, and GLP, considering elements such as indication, phase, and patient risk. Provide input to and perform reviews of Deviation, CAPA, and Change Management records.
• Partner closely with Nonclinical, Clinical Operations, CMC, and Regulatory teams to make risk balanced, time bound decisions that protect subjects, data integrity, and program timelines.
• Serve as the primary QA representative at internal cross‑functional clinical & non‑clinical team meetings, safety/PV meetings and program meetings.
• Provide QA oversight to non‑clinical, clinical and safety/ pharmacovigilance operations to ensure compliance with Tonix procedures and processes, both internally and externally in collaboration with contract research organizations (CROs) and investigator sites.
• Partner with study teams on vendor selection/qualification; conduct audits. Establish and manage nonclinical and clinical audit plans/schedules in collaboration with nonclinical and clinical development teams.
• Lead and/or support audits of clinical and nonclinical sites, vendors and studies, ensuring appropriate follow‑up and CAPA closure.
• Escalate reports of potential scientific misconduct or serious breaches, ensuring appropriate root cause analysis, documentation, and regulatory reporting.
• Review critical study documents (e.g. protocols, reports, ICFs, IBs, monitoring plans, manuals and other essential documents and regulatory submissions (e.g., IND) to ensure compliance with applicable regulations and industry guidance.
• Confirm that bioanalytical method qualification and validation studies are conducted in accordance with internal SOPs, ICH M10, and other applicable regulatory guidance as needed.
• Lead inspection readiness efforts as required. Chair/participate in mock inspections and interview training; storyboard key risks/issues and dossier positions; lead remediation sprints on identified gaps.
• Coordination and conduct of GCP/GLP training for Tonix personnel on Tonix processes, procedures, global regulations and guidance documents.
• Generate QA metrics for functional area management review, present at senior leadership meetings and escalate significant events to senior management.
• Evaluate new and/or revised regulatory or legal requirements and if applicable initiate implementation into the Quality System; conduct industry benchmarking.
• Follow all established occupational health and safety procedures, GxP requirements 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.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, & SKILLS

Required

• Bachelor's degree in Biological, Life Sciences or relevant discipline.
• 12+ years of experience in pharmaceutical drug development in Clinical & Non‑Clinical Quality Assurance
• Strong knowledge of relevant GLP/GCP FDA and ICH guidelines and regulations. Practical experience bridging GCP–GLP–GMP interfaces.
• Demonstrated success as a primary or sole QA lead supporting early‑ late phase clinical and nonclinical programs.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk‑based decisions, and exercise sound principles as they relate to clinical and non‑clinical topics. Experience presenting these outcomes to senior management.
• Hands‑on leadership of audits (CROs, sites, specialty vendors, bioanalytical labs) and inspection readiness with successful outcomes.
• Oversight of multiple product programs across the drug development lifecycle including extensive experience in clinical trials with small molecule drugs and biologics.
• Demonstrated experience in leading quality projects involving strong liaison with cross‑functional teams.
• Experience in GLP/GCP inspection preparation and management
• Knowledge of the US regulatory drugs and/or biologics approval process
• Experience in providing PV QA oversight preferred.
• Proficiency with Quality system applications (e.g., eDMS, QMS - Veeva)
• Ability to manage multiple projects in a fast‑paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Demonstrated leadership abilities including effective communication and interpersonal skills.
• Demonstrated excellent negotiation and collaboration skills.
• Dedicated team player who is able to withstand the high demands of a fast‑paced environment.
• Results driven, problem solver, and collaborator. Excellent written and verbal communication skills.
• Experience in budget forecast and planning

Salary Range

$150,000 - $240,000 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.

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.