Director, Clinical Quality & Inspection Intelligence

Alvotech; Göteborgs kommun; Presencial; SEK 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Alvotech, a biotechnology company focused on biosimilars, seeks a senior QA partner in iCMR to integrate quality advisory and oversight into clinical trials. You will deploy risk-proportionate QA strategies under CMQ, shaping the GCP audit program and driving innovations in data analytics for trial quality.

The role requires extensive GCP audit experience, leadership of cross-border teams, and strong communication in English plus another EU/EEA language.

Formación

• 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 in CRO; including in oncology, 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 in 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; process optimization and integration with digital tools; experience in utilisation of AI/ML highly preferred.
• Experience in leading of 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 authorisation in the EU and USA; and ICH and EMA guidelines governing clinical trials.

Responsabilidades

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

Conocimientos

GCP governance

Auditing

Quality assurance

Data analytics

AI/ML familiarity

Educación

MSc or PhD in pharmacology or life sciences

Herramientas

Veeva Clinical

Quality Vaults

Descripción del empleo

Alvotech, a biotechnology company focused on biosimilars, seeks a senior QA partner in iCMR to integrate quality advisory and oversight into clinical trials. You will deploy risk-proportionate QA strategies under CMQ, shaping the GCP audit program and driving innovations in data analytics for trial quality.

The role requires extensive GCP audit experience, leadership of cross-border teams, and strong communication in English plus another EU/EEA language.