Director, Clinical Quality & Inspection Intelligence

Alvotech; Sweden; On-site; SEK 1,200,000 - 1,500,000; Full time

Job summary

Alvotech seeks a senior quality role focused on direct quality partnership with iCMR leadership to ensure risk-proportionate quality assurance across clinical trials. The incumbent will deploy GCP oversight strategies, lead audits, and drive modernization and analytics initiatives within CMQ.

The position requires a MSc/PhD in life sciences, extensive GCP audit experience, and strong English plus another EU/EEA language. Travel and collaboration across multinational trials are expected.

Qualifications

• Advanced degree in pharmacology, healthcare, or life sciences.
• GCP Auditor qualification or equivalent credentials preferred.
• 10+ years in GCP-governed operations and audits in multidisciplinary, international clinical trials.

Responsibilities

• Develop, innovate, and improve GCP oversight and audit architecture for CMQ supervision of clinical studies.
• Ensure timely execution of the GCP audit program and quality evaluations of GCP providers.
• Lead data analytics initiatives to support quality improvement and inspection intelligence.
• Coordinate with study leads for ongoing GCP inspection readiness and follow-up.

Skills

Communication

Presentation skills

Data analytics

Digital tools

English proficiency

Education

MSc or PhD in life sciences

Tools

Veeva Clinical

Quality Vaults

AI/ML experience

Job description

Alvotech seeks a senior quality role focused on direct quality partnership with iCMR leadership to ensure risk-proportionate quality assurance across clinical trials. The incumbent will deploy GCP oversight strategies, lead audits, and drive modernization and analytics initiatives within CMQ.

The position requires a MSc/PhD in life sciences, extensive GCP audit experience, and strong English plus another EU/EEA language. Travel and collaboration across multinational trials are expected.