Manager, Quality Systems & Administration

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 www.Tonixpharma.com 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.

Position Overview:

The Manager, Quality Systems & Administration, 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 required.
• 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.

*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, 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.