Related skills
gcp eqms capa fda regulations qualio📋 Description
- Lead GCP quality across the business: audits, inspection readiness, and compliance.
- Hands-on GCP auditing of trials, sites, vendors, and processes; drive corrective actions.
- Prepare staff and materials for external sponsor audits and regulatory inspections; support follow-up.
- Assess/report serious breaches and quality issues; ensure proper reporting and resolution.
- Stay current with evolving regulations and translate into practical updates for teams.
- Lead a small quality team; embed quality across clinical ops; partner with external GCP support.
🎯 Requirements
- Hands-on GCP QA experience including planning and conducting audits.
- Knowledge of ICH GCP (E6 R2/R3) and FDA regulations.
- Experience preparing regulatory inspections (FDA/EMA) and sponsor audits.
- Experience building/maintaining a GCP quality management system (SOPs, CAPA).
- Ability to provide ad-hoc regulatory guidance to clinical operations.
- Experience with eQMS platforms (Qualio).
- Ability to manage and develop a small team; high agency.
🎁 Benefits
- Work on high-impact clinical trials
- Flexible scheduling and project variety
- Competitive contractor rates
- Stable, well-funded organisation
- Comprehensive support from our medical team
- The flexibility of working as a contractor
Meet JobCopilot: Your Personal AI Job Hunter
Automatically Apply to Operations Jobs. Just set your
preferences and Job Copilot will do the rest — finding, filtering, and applying while you focus on what matters.
Help us maintain the quality of jobs posted on Empllo!
Is this position not a remote job?
Let us know!