Senior Director, Quality Assurance Systems

About Tonix

Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases.

Position Overview

The Senior Director, Quality Assurance Systems oversees Tonix GxP Quality Management Systems for investigational and commercial products. The position’s responsibilities include oversight of Supplier Qualification, Internal Audits, Validation, Documentation and Training and overall Quality System management. The Senior Director oversees the development and optimization of quality systems and processes to ensure compliance with established standard operating procedures and regulatory agency requirements and guidelines. The position manages the internal inspection readiness program and provide support at all regulatory inspections, as well as evaluate emerging regulations. This role also leads the Quality Management Review process for reporting of Quality System metrics, developing new initiatives and process improvements.

Essential Duties

• Manage and oversee GxP functions including Documentation and Training, Supplier Quality, Validation, and Non-Clinical and Clinical Quality Assurance
• Develop and maintain QMS processes aligned with regulatory standards (e.g., FDA, EMA, ICH) and guidelines such as Internal Audit, Deviation, Change Control, CAPA, Complaint Handling and Risk Management
• Monitor emerging regulations and implement/revise internal processes
• Identify, assess and mitigate GxP-related risks in collaboration with cross-functional team members
• Ensure that regulated processes and systems at Tonix are phase appropriate and inspection-ready
• Lead, host, and manage regulatory inspections including follow-up activities
• Collaborate with and educate internal and external partners to implement a culture of Quality
• Lead Quality Management Review meetings to report Quality metrics, compliance trends, and any areas of risk with associated mitigation plans
• Oversee data integrity governance across GxP systems to ensure compliance with ALCOA++ principles and 21 CFR Part 11 requirements
• Manage and maintain a Quality Risk Management process that supports decision-making throughout the product lifecycle
• Provide leadership to Quality team members including hiring, performance management, mentoring and career development
• Assist in establishment and maintenance of department budget
• Follow all established occupational health and safety procedures, good practice quality guidelines and regulations (GXP’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

• Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application
• 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 is able to 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 25% of the time

Educational and Experience Requirements

• BS degree, preferably in a scientific discipline
• Fifteen (15) years of Pharmaceutical/Biopharmaceutical industry experience with ten (10) years of GxP Quality Assurance experience in US/EU environments preferred
• Eight (8+) years of direct supervisory experience with increasing responsibility over time
• Quality systems management and oversight
• Electronic Quality system applications (e.g., eDMS, QMS); Veeva Vault experience preferred
• Validation including computer software validation (CSV) oversight

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

Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit.

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.