Clinical QA Specialist II

Job Summary

The Clinical Quality Assurance Specialist II will be primarily responsible for the support of functional capabilities in Internal Audit and Inspection Readiness related to the quality management system across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) activities, Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP).

Essential Functions

• Provide support and quality review of Good Clinical Practice (GCP) documents (e.g. informed consent forms, protocols and amendments, investigators’ brochure, clinical study report, quality events, protocol deviations, etc.)  

• Participate as a CQA GCP representative on Clinical Trial Project Teams, providing GCP support and guidance 

• Represent CQA and provides GCP support and guidance to clinical project teams 

• Develop and review CQA department GCP Standard Operating Procedures (SOPs)   

• Independently generate controlled and supporting documents including SOPs, Clinical Investigator Site Audit/Regulatory Authority Inspection tools and templates, and training materials

• Support pre-, during and post activities related to the Clinical Investigator Site Audit Program  

• Conduct review of Clinical Investigator Site Audit documentation and ensure proper filing of audit deliverables    

• Participate in Clinical Investigator Site Audits as necessary 

• Participate in preparation of and support of GCP (Sponsor and Clinical Investigator Sites), and Good Clinical Laboratory Practice (GCLP) mock and actual regulatory authority inspections  

• Perform review of deliverables for mock and actual regulatory authority inspection  

• Provide CQA guidance to subject matter experts on preparation of deliverables 

• Review and support progress and follow up of Quality Events and Serious Breaches

• Assist teams in developing and implementing corrective and preventive action plans (CAPAs) and ensure follow-up through closure 

Required Knowledge, Skills, and Abilities

• Experience in review of GCP clinical trial documentation  

• Experience in support of mock and actual GCP/GCLP regulatory authority inspections 

• Knowledge of industry regulations and guidance across regulatory authorities (e.g., FDA, MHRA, EMA, etc.), including but not limited to ICH GCP E6, 21 CFR Parts 11, 50, 54, 56, 312, 314  

• Excellent understanding of GCP Quality Assurance Systems and Clinical Trial processes 

• Excellent comprehension of GCP and GCLP expectations; GVP knowledge a plus 

• Experience with eQMS (e.g. Orion, Veeva) 

• Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax

• Capable of managing multiple priorities, adapting and maintaining adherence to timelines

• Ability to troubleshoot, identify root causes and systematically resolve problems.

• PC literacy required; MSOffice skills (Outlook, Excel, Word, SharePoint and PowerPoint). Ability to adapt to changing software programs. 

• Willing to travel domestically and internationally (15%), as needed

Education, Experience, Licenses & Certifications

• Bachelor’s degree in biology, chemistry, engineering, or related field required

• A minimum of 3 years’ experience in a quality function within the Pharmaceutical/Biotech/Device industry.

• 5  years of quality assurance  experience strongly preferred