Clinical Quality Assurance (CQA) Manager

Location
Rockville, Maryland
Posted
May 21, 2022
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

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) Manager supports the Clinical Quality Management System to ensure:


  • 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


Responsibilities 


  • Supports implementation of a Clinical Quality Management System
  • Supports overall life-cycle management of clinical quality documents (partners with authors, reviews, releases, and rollouts)
  • Acts as GCP expert and provides support and responds to questions regarding GCP/QA
  • Supports development of quality documents for CQA function
  • Reviews all other clinical quality documents for compliance with regulations, company policies, and other quality documents
  • Follows and maintains system for deviation identification, investigation, root cause analysis, CAPA, tracking, and close-out
  • Provides and supports staff training regarding GCP, QA risk management, and quality documents
  • Partners with pharmacovigilance, pharmaceutical development, clinical operations, and manufacturing functions on quality issues
  • Participates and provides information and support for Annual Clinical Quality Review Meeting
  • Conducting and/or participating activities for Vendor oversight
  • Review of monitoring activities


Qualifications

 

  • Bachelor’s degree in life science or related field
  • 5+ 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
  • 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.