Vice President Of Quality Assurance

Company: Tonix Pharmaceuticals
Location: Chatham
Posted on: June 25, 2022

Job Description:

About Tonix*Tonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of immunology, central nervous system (CNS) and infectious disease product candidates. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. 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 OverviewTonix is searching for a strategic leader to build and lead the Quality Assurance (QA) function. This role is strategically important for the success of Tonix's near term goals, ensuring continuous improvement and high-quality deliverables. The individual in this position will be a hands-on leader responsible for direct management of quality personnel, develop and oversight of the quality systems, vendor audits and regulatory inspections, and assuring the overall GCP, GLP and GMP compliance with current regulations and guidelines.This is a highly visible role and can be either at the Executive Director or VP level based on candidate's ability and experience. This role in collaboration with Tonix management will set the Quality vision for the company.This fast-paced challenging position offers a competitive compensation and benefits package. This position will report directly to the Company's Chief Operating Officer and will be based at the Tonix Headquarters in Chatham, NJ or the Advanced Development Center (ADC) in North Dartmouth, MA.Essential Duties

• Develop and oversee implementation of GCP, GMP, and GLP Quality Management systems at appropriate Tonix locations and ensure GxP compliance for the organization
• Collaborate with the Clinical Operations, GLP-Tox., Regulatory Affairs and Product Development (CMC) teams to provide QA oversight throughout the product lifecycle
• Set the QA objectives in alignment with the overall corporate goals and objectives
• Implement the quality strategy and culture through collaboration, training, metrics, and risk-based thinking
• Ensure that regulated processes and systems at Tonix are phase appropriate and inspection-ready
• Take leadership responsibility for execution of Tonix audit programs, including annual audit plans, and oversee the performance of internal and external audits
• Lead, host, and manage regulatory inspections including follow-up activities
• Lead the GxP training program at Tonix
• Drive internal process improvement initiatives, such as, inspection readiness activities including mock inspections and interview preparations
• Collaborate with and educate internal and external partners to implement a culture of Quality
• Ensure all customer contracts, including Quality agreements, are effectively negotiated to meet the quality and regulatory requirements needs of Tonix in a cost-efficient manner
• Organize Quality Governance Meetings to report Quality metrics, compliance trends, and any areas of risk with associated mitigation plans
• Enhance policies and procedures and ensure compliance with applicable regulations
• Provide QA oversight of investigations, associated CAPAs, and Effectiveness Checks
• Identify, hire, manage and develop experienced Quality leaders and managers
• 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 as necessary to support Tonix on various business initiativesSupervisory Responsibilities
  • Recruits, interviews, hires, and trains new staff
  • Oversees the daily workflow of the department
  • Provides constructive and timely performance evaluations
  • Handles discipline and termination of employees in accordance with company policy
  • Contributes to performance and compensation decisions such as: merit raises, bonuses, and promotionsMinimum Qualifications
    • Bachelor's degree preferably in the life sciences
    • Twenty (20) years of Pharmaceutical Industry experience with fifteen (15) years of Quality Assurance experience in US/EU environment preferred
    • Ten (10) years in progressive Quality Leadership roles with proven ability to mentor and develop the QA teams through coaching and effective performance management
    • Extensive experience hosting regulatory inspections and interacting with regulators
    • Consistent track record of success in audit compliance
    • Excellent decision-making and strong communication skills and attention to detail
    • Knowledge of Risk Management systems and tools
    • Experience in Quality Systems Management and oversight
    • Strong knowledge of US-FDA, ISO, ICH, GxP principles, and other global regulations for drugs and medicinal products and their application
    • Demonstrated leadership experience in the vendor selection and management
    • Experience leading problem investigations, Root Cause Analysis (RCA), and CAPA
    • Experience with computer software validation (CSV) and implementation of systems.
    • Ability for travel up to 25% of the time
    • Dedicated team player who is able to 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 accommodationTonix offers salary commensurate with experience and an excellent benefits package.

Keywords: Tonix Pharmaceuticals, New York , Vice President Of Quality Assurance, Executive , Chatham, New York