Director, Clinical Quality Evaluation and Inspection Intelligence
Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines.
Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities.
iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position:
Overview of Job Role
This role primarily serves as a direct quality partner with relevant subject matter experts and leadership in iCMR to ensure integration of quality advisory and quality oversight in clinical trials. Reporting to Clinical and Medical Quality (CMQ) within Alvotech corporate quality unit, the incumbent will be responsible for deploying of risk-proportionate quality assurance and oversight tactics on assigned clinical programs/trials, as well as in other strategic initiatives in remit of CMQ, as relevant to innovation in iCMR and CMQ.
Scope and responsibility
- 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.
Job 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 in CRO; including in the following therapeutic areas: 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.
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