Compliance Head

5 months ago

Laval, Canada Moderna Full time

The Role

Here’s What You’ll Do

Implement Moderna’s overall Quality Management System (QMS) and quality manual, policies and procedures at the site. Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.

Oversee the performance and effectiveness of the QMS programs listed as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity. Lead Management review meetings and monitor the state of control of Moderna’s QMS at the site.

Maintain the site in a constant state of inspection readiness including the hosting of inspections. Be capable of running an effective and efficient backroom, and engage directly with Health Authority inspectors in the front room.

Serve as the site compliance representative on Global Compliance Councils, providing meaningful feedback on the QMS and how it impacts the site. Ensure awareness by the site of changes / initiatives and lead compliant implementation.

Work collaboratively with the Compliance organizations across Global and the sites, along with the digital team, in order to drive effective and efficient processes supported with digital e-systems. Build sustainable processes that enable compliant execution.

Here’s What You’ll Need (Minimum Qualifications)

Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 10+ years.

Demonstrated experience with Pharmaceutical Quality Systems.

Inspection experience preferred

Le Rôle

Voici Ce Que Vous Ferez

Implémenter le Système de Gestion de la Qualité (SGQ) global de Moderna, le manuel de qualité, les politiques et les procédures sur le site. Veiller à une amélioration continue, tout en se tenant informé des réglementations actuelles, des documents d'orientation et des meilleures pratiques de l'industrie.

Assumer un rôle de leader en matière de qualité et agir en tant qu'expert en conformité GXP. Superviser le processus de Qualité du site, notamment la Gestion des Déviations, la Gestion du Changement, les Notifications à la Direction, les Comités d'Examen des Matériaux, les Réclamations, les Revues de Gestion de la Qualité, et les Rapports aux Autorités Sanitaires.

Surveiller la performance et l'efficacité des programmes du SGQ, ainsi que la Gestion des Risques Qualité, la Formation, la Documentation et la Gestion des Dossiers, et l'Intégrité des Données. Piloter les réunions de revue de la Direction et assurer le contrôle du SGQ de Moderna sur le site.

Garder le site dans un état de préparation constante à l'inspection, y compris l'accueil des inspections. Gérer efficacement une salle arrière et interagir directement avec les inspecteurs des Autorités Sanitaires.

Évaluer les objectifs commerciaux, identifier les opportunités d'amélioration, faire preuve de pensée critique et appliquer des techniques de résolution de problèmes pour améliorer et maintenir la qualité du produit et l'efficacité du processus tout au long du cycle de vie du SGQ.

Représenter la conformité du site lors des Conseils de Conformité Globaux, en fournissant des retours constructifs sur le SGQ et son impact sur le site. Veiller à informer le site des changements et initiatives, et à diriger leur mise en œuvre conforme.

Collaborer avec les organisations de Conformité à l'échelle mondiale et sur les différents sites, ainsi qu'avec l'équipe numérique, pour promouvoir des processus efficaces et efficients soutenus par des systèmes numériques. Élaborer des processus durables pour une exécution conforme.

Voici Ce Dont Vous Aurez Besoin (Qualifications Minimales)

Diplôme de baccalauréat, de préférence en Sciences ou en Ingénierie avec une expérience industrielle de Qualité appliquée de plus de 10 ans.

Expérience démontrée avec les Systèmes de Qualité Pharmaceutique.

Expérience en inspection préférée

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class te

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