Clinical Quality Assurance CQA Director

Our Company

Founded in 2014 and based in Rockville, MD, NeoImmuneTech (NIT) is a clinical-stage T cell-focused biotech company dedicated to the discovery and development of novel immuno-therapeutics. At NIT, we strive to expand the therapeutic horizon in Immuno-Oncology and Infectious Diseases by greatly reducing the fatality and morbidity of life-threatening and debilitating diseases. Led by our scientific founder, who invented our lead asset NT-I7 (efineptakin alfa), we are science driven and patient focused. We believe that with NT-I7, the only clinical stage IL-7, we can enhance the body’s immune function to address key resistance mechanisms in Immuno-Oncology and deadly infectious diseases. We have a profound belief, rooted in our science, that we have the power to transform patient care with unique assets like NT-I7, and are committed to the pursuit of discovering their full potential in treating various diseases.

We Offer

• Remote and hybrid work opportunities
• Competitive pay
• Annual promotion opportunities
• 401(k) + company matching - 100% vests immediately!
  
• Free medical insurance
• Flexible Spending Account (FSA)
• Free life insurance
• Paid time off
• Paid holidays
• Paid sick leave
• Paid Family Medical Leave
• Free lunches, snacks, and drinks 
• Cell phone reimbursement
• Internet reimbursement
  

Job Summary

The Clinical Quality Assurance (CQA) Director supports the Clinical Quality Management System to ensure:

• Development of quality management system to comply with FDA and EMA regulatory requirements
• Compliance with regulatory and company Ethical and Good Clinical Practice (GCP) requirements
• Patient safety and data integrity respected
• Risks identified, investigated, corrected, and communicated to Head of CQA
• Clinical staff, trials, and sites always inspection ready
• Leads CQA efforts in US

Responsibilities 

• Leads risk management and gap analysis of current practices based on GCP and GLP compliance
• Develops and implements standards, policies, and procedures for GCP/GLP regulatory compliance
• Interprets and provides oversight of GCP and GLP regulations, standards, and quality systems compliance
• Leads regulatory inspection preparedness, internal and external audits, and coordinates responses to regulatory authorities
• Leads gap analysis of process, process improvement, and quality optimization activities
• Develops and implements GCP compliance strategies and provides compliance guidance to encourage process improvement across the organization
• Creates and implements audit strategy for all CQA programs
• Leads out-sourced audit activities
• Plans and leads GCP and GLP compliance audits (US and international), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks
• Leads GCP/GLP training of functional areas and develops training for staff involved in execution of clinical trials and nonclinical studies
• Leads CQA meetings to discuss QA/GCP issues and align approach with other divisions and external partners
• Reviews, participates, and approves deviation document that includes deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
• Prepares and submits annual audit plan and report based on risk assessment of each vendor, performance, and qualification status
• Responsible for reporting and escalating compliance issues to management including requests for directed audits
• Responsible for managing QA reviews of project related clinical study documents
• Partners with Pharmacovigilance, Pharmaceutical Development, and Operations functions on quality issues
• Partners with other divisions to effectuate risk management plans for clinical activities
  

Qualifications

• Bachelor’s degree in life science or related field; master’s degree preferred
• 12+ years of relevant experience in CQA
• Risk assessment experience in CQA
• Vendor audit experience in CQA
• Experience in training program management
• Experience in data verification (CSR)
• Solid understanding of drug development process with a special emphasis on regulatory requirements at each development stage for clinical at EMA and FDA
• Working knowledge of clinical research/development
• Working knowledge of ethical principles, regulatory requirements, and GCP/GLP
• Demonstrates good judgment and critical thinking skills
• Excellent communication skills
• Up to 30% travel required (not applicable during the COVID-19 pandemic)

NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

If you require assistance to complete a job application, please email us at hr@neoimmunetech.com.