QA Manager, GCP

📋 Description

• Oversee QA and quality by design for GCP/GCLP area.
• Provide QA guidance for audits, inspections, and risk assessment of submissions.
• Support data for Audit program risk assessment and quality reviews.
• Ensure quality perspective in clinical studies across Sobi.
• Coordinate with stakeholders across Sobi organization.
• Maintain and contribute to GCP inspection readiness and QA processes.

🎯 Requirements

• Life Sciences degree or similar in related field.
• 5+ years in pharmaceutical clinical QA or GCP audit/QA roles.
• Strong knowledge of ICH GCP, FDA/EMA/regulatory requirements.
• QA systems experience and auditing background.
• Structured, results-focused, detail-oriented with strong interpersonal skills.

🎁 Benefits

• Competitive compensation and total rewards.
• Generous time off and work-life balance.
• Opportunities to attend conferences.
• Collaborative, team-oriented environment.
• Impactful work improving ultra-rare disease therapies.