[Hiring] Director, Clinical & Nonclinical Quality Assurance @Tonix Pharmaceuticals

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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.

• 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.
• Ensure adherence to GCP, GcLP, and GLP regulations and develop a quality oversight model for preclinical study management.
• Oversee audit professionals/consultants with principal responsibility for quality oversight of regulated study activities.
• Collaborate cross-functionally as an advocate for quality standards and explain these quality standards to other functions.
• Support activities both internally and at Tonix contracted organizations including regulatory inspections, third-party audits, risk assessments, deviations, CAPAs, and change controls.
• Lead, direct, and advise continuous improvement of the department’s area of control.

Qualifications

• 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.
• 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.
• Hands-on leadership of audits and inspection readiness with successful outcomes.
• Oversight of multiple product programs across the drug development lifecycle.
• 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.
• Demonstrated leadership abilities including effective communication and interpersonal 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.

Requirements

• Experience with capital project commissioning and qualification.
• 2-4 years of experience with personnel management and development.
• ASQ certification (e.g., certified quality engineer, quality auditor, manager of quality/organizational excellence).
• Working knowledge of bioanalytical method development, qualification, and validation activities in support of clinical & non-clinical studies.

Benefits

• Medical, Dental & Vision Insurance
• Basic and Voluntary Life and AD&D Insurance
• Short- and Long-Term Disability Insurance
• Flexible Spending Accounts
• Health Savings Account
• 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 Salary Range $150,000 - $240,000 USD Apply tot his job

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