Medical Director

• Develop and continuously improve the GCP quality oversight and audit architecture enabling risk-proportionate CMQ supervision of clinical studies
• Ensure timely execution of the GCP audit program and quality evaluations of GCP service providers; may act as Lead Auditor for assigned audits
• Lead modernization and data analytics initiatives in CMQ to deploy solutions enabling quality innovation
• Define and own the inspectional intelligence framework for clinical study activities, including signal detection, trend analytics, and insight-to-action workflows
• Contribute to risk-management activities for GCP processes, computerized systems, and studies
• Coordinate with function and study leads on ongoing GCP inspection preparedness, coordination, and follow-up
• Act as QA approver of audit reports, serious noncompliance investigations, high-risk CAPA, and selected procedural documents
• Act as CMQ lead on one or more complex studies
• Represent CMQ on internal and external governance boards
• Lead a team of CMQ managers

Explore Director, Clinical Quality Evaluation and Inspection Intelligence at Alvotech. Review requirements and application details.