GCP QA Standards and Training Consultant

GCP QA Standards and Training Consultant

Term: 1 year

Industry: Pharma

Location: Client in Northern NJ, this role is remote

Ideally able to go to office on occasion


The Consultant, GCP Quality Assurance will assist the Head of CQA in revising the CQA Standards/SOPs, upskilling auditing practices for CQA staff, develop & deliver training (where applicable).

1. Perform gap analysis of current CQA Standards and CQA staff skill set
2. Develop plan for revision of current Processes/ SOPs
3. Develop roadmap for Skill set training
4. Revise or create new SOPs
5. Develop CQA training materials
6. Deliver training


  • Minimum of 5-8 years of Clinical Quality Assurance and auditing experience
  • Experience in SOP development
  • Experienced trainer
  • Experience with inspection management
  • Knowledge of ICH GCP, clinical trial methodology, and specific knowledge of applicable regulations/guidance (including 21 CFR Part 11) and ICH Guidelines related to clinical computer systems

Location: remote

  • Accepted file types: doc, pdf, txt, docx.