Job Description
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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