Job Description
📋 Description Oversee GCP audit management end-to-end and provide QA guidance across audits Support risk assessments for audits, inspections and submissions under global QMS Assist data gathering for Audit program risk assessment and trending Contribute to QA perspective on clinical studies activities across Sobi Ensure qualification of ESP in GCP-regulated areas per Sobi procedures Collaborate with stakeholders and act as QA representative during GCP inspections 🎯 Requirements University degree or similar in Life Sciences or related discipline 5+ years in pharmaceutical industry QA or clinical trials with GCP audit experience Strong knowledge of ICH GCP, FDA/EMA and ROW regulations QA principles and QA systems experience; auditing background preferred Structured, results-focused with strong interpersonal and collaborative skills 🎁 Benefits Competitive compensation for your work Generous time off policy Opportunities to attend popular conferences Emphasis on work/life balance Collaborative and team-oriented environment Impactful work helping patients with ultra-rare diseases
