Manager, Quality Systems Berkeley Heights, NJ or North Dartmouth, MA

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-BorreliaOspA 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 and follow the Company onLinkedIn andX . *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 The Manager, Quality Systems situated within the Quality Assurance department, will provide support for the Veeva electronic Document and Quality Management systems (QDocs, Training, eQMS, and RIM) systems. This position will be responsible for providing ongoing system administration, access management, configuration, and maintenance activities, as well as user support, and ensuring these systems are in an operational state of compliance associated with cGMP manufacturing environments, GxP requirements, and internal policies. They will ensure consistent application of policies, procedures, and work instructions associated to these systems, as well as adherence to regulatory requirements. This position will also manage the reconciliation and archiving process of paper documents, electronic signature workflows (e.g. DocuSign), document uploads into Veeva QDocs in support of area departments as needed. The Manager, Quality Systems & Administration will collaborate cross-functionally for on-going activities in support of continuous improvement initiatives system and workflow enhancements and assist in any other area as needed or directed by management. Responsibilities Perform Business Administrator activities in the Veeva Quality Management Systems (QDocs, Training, eQMS, & RIM), including management of user roles, permissions, and access controls. Provide configuration support of Veeva Vault Quality modules (e.g., QMS, Docs, Training), including management of document lifecycles, workflows, templates, and metadata. Participate in the assessment of impacts related to configuration changes and/or, system releases. Execute user test scripts related to system changes, as needed. Work with other Veeva System Leads and Veeva System Administrators to ensure continuity across workstreams Manage document and/or event workflows to support end users. Manage and/or support electronic signature workflows and envelopes (e.g. DocuSign), and document uploads into Veeva QDocs in support of area departments as needed. Support user training sessions, onboarding, and refresher training for Veeva Vault applications. Assign and/or revise user training plans and curricula in alignment with area department needs, as appropriate. Support the reconciliation and archiving process of paper documents. Identify opportunities to enhance system usability, workflow efficiency, and user experience. Perform other projects related to the improvement of quality systems as needed and required by management, including the Veeva eQMS system. Participate in regulatory inspection, internal audits, supplier audits (as needed), and audit response activities. Ensure compliance with all applicable policies, procedures, and regulatory requirements Necessary Skills and Abilities Veeva Vault Certification (Administrator, Quality Suite) or equivalent SME-level experience administering and configuring Veeva Vault is preferred. Working knowledge of GxP processes associated with Veeva Quality Docs, Training, eQMS, and RIM applications (e.g., document change control, training, deviation management & CAPA). Proficiency in Microsoft office applications, including formatting of MS Word document & Excel spreadsheets. Strong documentation, organization, and communication skills; ability to collaborate effectively with technical and non-technical stakeholders Dedicated team player who is able to withstand the high demands of a fast-paced environment. Excellent planning and time management skills and the ability to handle several tasks simultaneously. Comfortable working independently with minimal supervision. Strong troubleshooting and problem-solving skills. Excellent communication skills with the ability to collaborate across functional teams Must lead by example through strong work ethics and high standards. Ability for travel up to 10% of the time Qualifications Bachelor’s degree or higher. 8+ years of experience in the biotech/pharmaceutical industry, with a minimum of 4 years situated within a Quality Management Systems function or equivalent. Extensive experience in Veeva Vault Systems Administration and configuration. Experience with previous implementation of Veeva Vault platforms and systems migration. Preferred Experience in managing a document archival room and coordination with off-site storage procedures. Experience in executing test scripts to support system updates and releases. Experience with Veeva PromoMats, and/or other EDMS/QMS/LMS systems. Salary Range

$100,000 - $145,000 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. 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. #J-18808-Ljbffr Tonix Pharma Limited