Senior Manager, QA Validation
hace 13 días
Chatham
Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. About the Role The Senior Manager, Validation, situated within the Quality Assurance department, will provide quality support on validation activities for internal and external (i.e., contract organizations) GxP computer systems and data integrity processes. This position will be responsible for ensuring equipment and systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies. They will ensure consistent application and maintenance of Validation procedures This position will collaborate cross-functionally for on-going activities in support of validation activities occurring both internally and at Tonix contracted organizations including support of risk assessments, deviations, CAPAs, and change controls. The Senior Manager, Validation, will lead, direct, and advise continuous improvement of the department’s area of control, and assist in any other area as needed or directed by management. Essential Duties • Ensure the validated status of GxP computer systems used to support GxP activities, is established in accordance with internal procedures, regulatory requirements and industry guidance / standards., • Define computer system validation policies and overall strategies and ensure compliance and consistency with regulatory requirements and best industry practices., • Responsible for maintaining the CQV and CSV programs in a state of compliance., • Establish and provide quality and technical input on the development of policies, procedures, standards and templates, • Review and approve technical documents throughout the equipment/system lifecycle from commissioning, qualification and/or validation through decommissioning, including validation plans, risk assessments, test protocols and reports., • Develop validation and testing strategies based on system risk, complexity, and other relevant factors and ensure all validated systems and documentation comply with applicable regulatory requirements., • Assist with the development of system requirements and specifications to ensure requirements are testable and 21 CFR Part 11 requirements are met. Implement and ensure effective data integrity controls and practices., • Evaluate proposed changes to validated computer systems and recommend the level of validation activities required., • Manage and perform all Quality System functions for the department including impact assessments, deviations, CAPAs, change controls, SOP revisions, and audit responses., • Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities., • Must comply with all applicable rules and regulations of Emergent and Pharmaceutical/Biotech industry. This includes FDA regulations such as cGMP, GDP, EH&S regulations, and company regulations. Will maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation., • Define and communicate metrics used to track performance relevant to the operations qualification programs’ activities / responsibilities and ensure commitment to key stakeholders and company goals are met., • Proficiency with Quality system applications (e.g., eDMS, QMS), • 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, • Excellent planning and time management skills and the ability to handle several tasks simultaneously., • Comfortable working independently with minimal supervision, • Ability for travel up to 20% of the time, • Must be able to provide clear direction while motivating teams., • 10+ years of experience in the biotech industry and 2+ years of management experience., • Demonstrated knowledge of cGMPs for biotechnology, validation-related topics, and key industry validation approaches (e.g., validation lifecycle approach, ASME BPE, PIC/S ISPE Baseline Guides ASTM E2500, GAMP 5, V-model, etc.). Complementary knowledge of biopharmaceutical and process engineering principles and practices., • Demonstrated experience in IT System/Software Development Life Cycle (SDLC), change controls, validation needs, and activities., • Demonstrated expertise in Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems, e.g., GxP, validation, 21 CFR Part 11, CSA, etc., • Strong understanding of ICH Q7, Q8, Q9, Q10 and other international regulatory guidance is critical., • Experience with personnel management and development., • Strong project management skills., • Working knowledge in Facility, Utility & Equipment Qualification, Process Validation, and Quality System Management. 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 $100,000 to $170,000 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
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