Location: Dartmouth,MA, USA
About Tonix Tonix is a biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on commercializing, developing, discovering and licensing therapeutics to treat and prevent human disease. Tonix markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg. Zembrace SymTouch and Tosymra are each indicated for the treatment of acute migraine with or without aura in adults. Tonix's development portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix's CNS development portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. The Company's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. Tonix's infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, which also serves as the live virus vaccine platform or recombinant pox vaccine platform for other infectious diseases. Position Overview Tonix is seeking a full-time QA Documentation and Training Lead to effectively perform activities related to the development and management of the Tonix Quality Assurance documentation and training program and processes. This position would be responsible for supporting routine Veeva updates and implementing any additional functionality or processes. This position would also be responsible for managing daily documentation and training activities, with the majority of the work conducted in Veeva Vault Systems. The position will support all aspects of this process including assisting with managing user accounts, providing compliance guidance and performing training, particularly related to the Tonix eDMS and LMS. This is a fast-paced, challenging position that offers a competitive compensation and benefits package. This role is an exempt (salaried) position that will report directly to the QA Manager of Documentation and Training and be based at the Tonix ADC North Dartmouth, MA location in a hybrid capacity. Essential Duties Maintain processes for the Quality Assurance documentation and training program, including conducting impact assessments on the quality systems.Support electronic periodic reviews of the system including but not limited to routine system updates. Assist training manager with training effectiveness process Create, revise and retire training curricula and plans Assist in identifying opportunities to improve training processes by implementing new tools and best practices. Assist with creation and assignment of training materials for different levels of users. Lead document control training including but not limited to onboarding training and provide ongoing support on effectively using Veeva QualityDocs. Collaborate with cross-functional teams to align and integrate documentation and training efforts, with a particular focus on managing document change control (DCC). Prepare and monitor metrics to ensure the quality management system remains in control. Assist with internal audit and regulatory inspection activities Follow all established occupational health and safety procedures, good manufacturing practices (GMP's) and standard operating procedures (SOP's) Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork Perform ad-hoc work/special projects to support Tonix on various business initiatives Minimum Qualifications Bachelor's degree in a scientific field or related discipline five (5) years of Quality Assurance Documentation and Training experience At least three (3) years of eDMS experience preferred Demonstrated knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management Proficient with Microsoft Office applications (e.g., Word, Excel) Experience in drafting, revising, and retiring documents, as well as assessing their impacts on the system. Skilled in conducting periodic reviews of document and training effectiveness Experience in generating KPI reports, demonstrating strong analytical skills Experience with internal audits and inspections, preferred Ability for minimal travel Dedicated team player who can withstand the high demands of a fast-paced environment Excellent written and verbal communication skills are essential Strong planning and organizational skills Comfortable working independently with minimal supervision Highly organized, results driven, problem solver, and collaborator Demonstrated ability to perform the essential duties of the position with or without accommodation 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 Annualized base salary ranges from $60,000 to $90,000 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 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, disability, veterans status, 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.