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.

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