Director, Quality Assurance Operations

Position Overview

Shape the quality standards that support reliable supply, protect patients, and advance responsible growth.

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 shape and execute quality operations and compliance strategies that advance corporate objectives, meet regulatory requirements, and support business growth.

Guided by Tonix's core values of integrity, commitment, innovation, and passion, the Director champions sound quality decisions, strengthens operational performance, and develops a culture of accountability and continuous improvement. This role maintains accountability for Quality Operations program effectiveness, directs departmental activities through staff, and serves as the final Quality decision-maker for assigned operational quality matters. Responsibilities include departmental budget management, resource planning, organizational effectiveness, and quality compliance outcomes across internal operations and external business partners.

Key Responsibilities

• Shape and execute the Quality Operations strategy in partnership with senior leadership to advance commercial and development programs.

• Partner with senior management to establish long-term quality, compliance, inspection readiness, and operational objectives.

• Lead Quality Operations across multiple functional areas, driving departmental performance and achievement of strategic objectives.

• Establish clear departmental goals, meaningful performance metrics, and resource plans aligned with organizational priorities and business objectives.

• Identify, evaluate, and communicate product quality and compliance risks and drive effective mitigation strategies. Serve as the final Quality authority for operational quality decisions affecting assigned products, processes, and compliance programs, including quality risk assessments, compliance remediation plans, and escalation actions.

• Lead, coach, and develop a multi-level Quality organization, building technical expertise, accountability, and leadership capability. Exercise authority for hiring, performance management, compensation recommendations, promotions, succession planning, disciplinary actions, and terminations.

• Approve staffing plans and workforce allocations, aligning departmental resources with business and compliance objectives. Guide organizational design and resource planning to strengthen departmental effectiveness.

• Build trusted relationships with contract Quality organizations to resolve quality issues promptly and reinforce shared accountability.

• Partner with internal project teams to uphold Quality Management System (QMS) requirements and strengthen practices for quality record generation and timely closure.

• Direct lot disposition activities to support commercial and clinical supply needs. 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), contribute quality-related content, and translate trends, findings, and risks into recommendations for improvement.

• Oversee Good Distribution Practice (GDP) and Drug Supply Chain Security Act (DSCSA) compliance activities to safeguard compliant distribution, product traceability, and supply chain security.

• Oversee artwork management processes to ensure compliant control, approval, and implementation of labeling and packaging materials.

• Lead third-party audits and participate in internal audits and regulatory inspections to assess compliance and identify opportunities for improvement.

• Review regulatory submission documentation related to New Drug Applications (NDAs), Biologics License Applications (BLAs), Investigational New Drug applications (INDs), information requests, and annual reports.

• Translate quality metrics into actionable insights for functional teams and Quality management. Highlight emerging risks, recommend actions, and monitor implementation of mitigation and preventive measures.

• Author, review, and/or approve clear, effective internal policies, procedures, and quality documentation.

• Develop and manage the Quality Operations budget with accountability for financial performance. Approve departmental expenditures and resource allocations, implement corrective actions to meet budget objectives, and provide 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 progressively increasing responsibility preferred.

• Proficiency with electronic Quality system applications, including electronic document management systems (eDMS) and QMS; Veeva Vault experience preferred.

• Experience participating in or hosting regulatory inspections and interacting with regulators preferred.

• Experience with commercial GxP processes, including Good Distribution Practices and DSCSA requirements.

• Strong knowledge of US FDA requirements, ISO standards, ICH guidelines, GxP principles, and other global regulations for drugs and medicinal products, including their practical application.

• Direct experience managing Quality System activities within regulated pharmaceutical or biotechnology environments.

• Knowledge of the drug development and commercialization process.

• Sound judgment in recognizing and appropriately escalating Quality, product, and/or patient safety issues.

• Excellent written and verbal communication skills, with the ability to communicate quality expectations, risks, and decisions clearly.

• Strong planning and organizational skills, with the ability to prioritize competing demands and follow through on commitments.

• A collaborative approach to achieving shared goals and maintaining high quality standards in a fast-paced environment.

• Ability to work independently, exercise sound judgment, and take ownership with minimal supervision.

• A results-driven approach to solving problems, partnering across functions, and turning insights into practical improvements.

• Demonstrated alignment with Tonix's core values: integrity in quality decisions, commitment to reliable execution and accountability, innovation in strengthening systems and processes, and passion for quality and patient safety.

• Demonstrated ability to perform the essential duties of the position with or without accommodation.

• Ability to travel up to 20% of the time.