QA Manager, GCP

📋 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