Director, Clinical Quality Evaluation and Inspection Intelligence

🔥 0 minutes ago

🌐 Sweden, United Kingdom, +1 more countries – Remote

🇸🇪 Sweden – Remote 🇬🇧 United Kingdom – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Alvotech

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $78.3M Post IPO equity on 2025-07

Biotechnology • Pharmaceuticals • Healthcare

Alvotech is a biopharmaceutical company that specializes in developing and manufacturing biosimilars—biologic medicines highly similar to approved reference biologics—to increase global patient access to affordable biologic therapies. The company follows a vertically integrated approach, covering cell line development through fill-and-finish manufacturing, and partners with commercialization experts to bring products to market. Its pipeline includes proposed biosimilars to high-profile biologics, and it emphasizes scale, control and speed in production. Alvotech operates globally and focuses on improving access to biologic medicines.

📋 Description

• 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

🎯 Requirements

• MSc or PhD in pharmacology, healthcare, or other relevant life sciences • Holder of GCP Auditor qualification evidence / credentials issued by an internationally recognized organization, e.g. SQA RQAP-GCP, EFGCP, etc.; ACRP-CP or CCRA/CCRC credentials preferred • Minimum 10 years of combined experience in GCP-governed operational and audit roles with multi-centric international clinical trials in biopharmaceutical companies or CROs • Experience in oncology and immunology; ophthalmology and neurology experience preferred • Minimum 5 years of intensive exposure to GCP inspections by FDA, EU Member States authorities, and PMDA; MHRA / ANVISA inspection experience desired • Minimum 5 years conducting GCP audits of clinical investigator sites, GCP service providers, eTMF, and other computer systems / digital health technologies in clinical studies • High digital acumen and experience with Veeva Clinical and Quality Vaults • Experience with process optimization and integration with digital tools • Experience in utilization of AI/ML highly preferred • Experience leading decentralized teams • Excellent communication, writing, and presentation skills in English and at least one other official EU/EEA/RS language • Demonstrated outstanding understanding of regulatory procedures for biological medicines authorization in the EU and USA, and ICH and EMA guidelines governing clinical trials

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