Clinical Quality Assurance Manager/Sr. Manager

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 long-acting human 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

• Hybrid work opportunity
• 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

Clinical Quality Assurance (CQA) Manager/Senior Manager provides advice and guidance to clinical teams concerning GCP compliance, contributes to study management decisions from quality perspective, and ensures clinical trials are performed in accordance with applicable SOPs, study protocols and all applicable regulatory requirements

Responsibilities 

• Manages implementation of the Clinical Quality Management System (QMS) and Clinical Quality SOPs to ensure compliance to ICH E-6 Guideline for Good Clinical Practice in clinical, medical and regulatory activities
• Manages development of clinical quality SOPs, policies, work instructions, and their document life cycle
• Manages audit plan, audit conduct and CAPA follow up. Proposes audits to assess areas of study risk
• Acts as GCP expert and provides support and responds to questions regarding GCP/QA and potential non-compliance topics
• 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
• Participates and provides information and support for Annual Clinical Quality Review Meetings for overall QMS compliance, Risk Management and Audit planning
• Participates in vendor oversight and project management meetings to provide updates on CQA topics
• Reviews clinical study documents for compliance with regulations, company policies, applicable SOPs, and other quality documents
• Leads GCP Clinical Inspection Readiness (IR) and hosts regulatory inspections and partner audits
• Partners with pharmacovigilance, pharmaceutical development, clinical operations, and manufacturing functions on quality issues
• Partners with other divisions to effectuate risk management plans for clinical activities
• Supports risk assessments, monitors effectiveness of Risk Mitigation and Risk Prevention approaches, and supports the conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance
• Identifies when significant changes/improvements to business processes are needed across R&D and beyond and shares with process improvement team. Identifies strategic solutions for continued improvement across clinical, where needed.
• Other duties as assigned

Qualifications

• Bachelor’s degree in life science or related field; Master’s preferred
• 5+ years of relevant experience in QA

• Experience in training program management
• Experience in data verification (CSR, SDV)
  
• Experience with GCP, GCLP, PV, RA, Data integrity, Part 11, TMF and/or Clinical Site Audit
• Risk assessment/management experience in CQA
• Solid understanding of drug development process and GCP compliance regulations in clinical operations and CQA
• Strong Project Management Skills
• Good understanding of end-to-end clinical trial processes and functions including experience in one or more clinical trial operations functions/sub-functions
• Experience with FDA, EMA, CFDA or other regulatory inspections of sponsor, investigator sites, or CROs; leadership role is a plus
• Demonstrates good judgement/critical thinking skills and self-motivation
• Excellent communication skills (written and verbal)
• 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-us@neoimmunetech.com. 

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