Senior QA leader at a commercial-stage biotech who owns quality operations for commercial and clinical manufacturing, distribution, and supply chain — lot disposition, GDP/DSCSA compliance, audits, regulatory submission reviews, and team/budget management. Works with eQMS/eDMS systems, ideally Veeva Vault; based on-site in NJ or MA.
Compensation
$180K–$220K / yr
Location
Berkeley Heights, NJ or North Dartmouth, MA
Work setup
Not specified
Seniority
Not specified
Employment
Contract
Experience
15+ years
Category
Qa
Posted
Skills
corrective-action
performance-management
risk-assessment
succession-planning
vault
veeva
Must have
B.S. degree, preferably in a scientific discipline
10 years pharmaceutical/biopharmaceutical industry experience
Proficiency with electronic Quality system applications, including eDMS and QMS
Experience with commercial GxP processes, including GDP and DSCSA requirements
Strong knowledge of US FDA requirements, ISO standards, ICH guidelines, GxP principles, and other global drug regulations
Direct experience managing Quality System activities in regulated pharmaceutical or biotechnology environments
Knowledge of the drug development and commercialization process
Sound judgment in recognizing and escalating quality, product, and/or patient safety issues
Excellent written and verbal communication skills
Strong planning and organizational skills, prioritizing competing demands
Collaborative approach in a fast-paced environment
Ability to work independently with minimal supervision
Results-driven approach to problem solving and cross-functional partnering
Alignment with Tonix core values: integrity, commitment, innovation, passion
Ability to perform essential duties with or without accommodation
Ability to travel up to 20% of the time
Nice to have
7 years of Quality Assurance experience in US/EU environments
7 years of direct supervisory experience with progressively increasing responsibility
Veeva Vault experience
Experience participating in or hosting regulatory inspections and interacting with regulators
Full 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 and follow the Company on LinkedIn and X.
*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
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
Director, Quality Assurance Operations at Tonix Pharmaceuticals (Berkeley Heights, NJ or North Dartmouth, MA) — aijobsearch
- 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.
- 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.
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, 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.