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
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