San Diego, CA30+ days ago
Key responsibilities: • Ensure GCP Audits management excellence of the end-to-end audit management process and overview of the assigned audits, as planned • Assess and approve from quality perspective the GCP deviations (global and local, as applicable), GCP related CAPAs • Prepare regular status report on performed audits, audit trending, deviation trending, CAPAs trending and agreed upon metrics to ensure Quality oversight • Contribute and support the GCP audit risk assessment according to SOPs • Ensure active contribution in the cross-functional team with procurement, business owners for GxP and Quality requirements and documented qualification of GCP service providers and review provisions in contracts/Quality agreements, as applicable • QA representative during GCP inspections global and site level, as applicable and contribute to the Inspection Readiness framework and promote continuously quality mindset across Sobi • Authoring GCP QA related processes, review and give guidance under global umbrella.
Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team:
• Competitive compensation for your work • Generous time off policy • Opportunity to broaden your horizons by attending popular conferences • Emphasis on work/life balance • Collaborative and team-oriented environment • Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments.