Director, Clinical and Nonclinical Quality Assurance

Role Summary

The Director, Clinical & Non-Clinical Quality Assurance, located 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 role will collaborate cross-functionally as an advocate for quality standards and will explain these quality standards to other functions, serving as a subject matter expert and advisor on meeting these standards. It will support activities both internally and at Tonix contracted organizations, including regulatory inspections, third-party audits, risk assessments, deviations, CAPAs, and change controls. The Director will lead, direct, and advise continuous improvement of the department’s control area and assist in any other area as needed by management.

Responsibilities

• 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 of 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.

Qualifications

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