Director, Clinical Quality & Inspection Analytics

SE10 Alvotech Sweden AB

Sweden

Remote

SEK 1,600,000 - 2,100,000

Full time

11 days ago

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Job summary

Alvotech is seeking a senior QA professional to partner with iCMR and CMQ to deploy risk-proportionate quality assurance across clinical programs. You will lead GCP audits, act as CMQ lead on complex studies, and drive inspection preparedness and signal analytics for clinical trials.

The role requires MSc/PhD in life sciences and a GCP Auditor credential, with 10+ years in GCP-governed roles, including international trials.

Qualifications

Requires MSc or PhD in pharmacology, healthcare, or life sciences.
GCP Auditor qualification credentials (SQA RQAP-GCP / EFGCP or equivalent) preferred.
Minimum 10 years in GCP-governed audits/operation with multicenter trials.
Minimum 5 years in conducting GCP audits of sites, providers, and ICH/EMA-guidance contexts.
Strong digital acumen with experience in modern QA tools and AI/ML is highly valued.

Responsibilities

Develop, innovate, and improve GCP quality oversight architecture for CMQ supervision of clinical studies.
Lead audits, evaluate GCP-service providers, and approve audit reports.
Coordinate inspection preparedness and escalation with study leads and CMQ leadership.
Act as CMQ lead on complex studies, and represent CMQ in governance boards.
Lead a team of CMQ managers and drive risk-management activities for GCP processes.