QA Operations Head

6 months ago

Laval, Canada Moderna Full time

The Role

Here’s What You’ll Do

**Manage a team of QA professional responsible for**: On-the-Floor manufacturing oversight, Deviation Management, Change Management, Batch Record Review and Product Disposition. Demonstrate dynamic range with the capability to also directly support these expectations.

Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.

Monitor key quality system metrics and process indicators to ensure adherence to compliance and performance expectations. Engage in plant tiered governance that supports performance expectations that includes quality, delivery, and safety.

Role model Quality Culture and the Moderna Mindsets. Collaborate closely with cross-functional partners and as an active member of leadership.

Support the training and development of the QA team including coordination of training, capability assessment and enhancement, and professional development.

Author, review and/or approve documentation, including SOPs, to ensure compliance and adherence to regulations/cGMP operations.

Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Utilize knowledge to improve operational efficiency.

Interface directly with Health Canada or other regulatory authorities and ensure Moderna is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs).

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

Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience

8 - 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Demonstrated ability making risk based decisions

Le Rôle

Voici Ce Que Vous Ferez

Diriger une équipe de professionnels de l'Assurance Qualité en charge de la surveillance de la fabrication sur le terrain, la Gestion des Déviations, la Gestion du Changement, la Revue des Dossiers de Lot et la Disposition du Produit. Faire preuve de dynamisme et d'aptitude à soutenir directement ces attentes.

Veiller au respect des bonnes pratiques de fabrication actuelles, des procédures d'exploitation standard, et de la documentation de fabrication.

Surveiller les indicateurs clés de performance du système de qualité et les indicateurs de processus pour assurer le respect des attentes de conformité et de performance. Participer à la gouvernance de l'usine sur plusieurs niveaux, qui soutient les attentes de performance incluant la qualité, la livraison, et la sécurité.

Incarnant la Culture de Qualité et les Mentalités de Moderna. Collaborer étroitement avec les partenaires inter-fonctionnels en tant que membre actif du leadership. Soutenir la formation et le développement de l'équipe QA, y compris la coordination de la formation, l'évaluation et l'amélioration des compétences, et le développement professionnel.

Rédiger, réviser et/ou approuver la documentation, y compris les SOP, pour assurer la conformité et le respect des opérations/réglementations cGMP.

Promouvoir l'amélioration continue dans tous les aspects de la gestion totale de la qualité à travers une main-d'œuvre bien formée, des processus d'affaires simplifiés, et des opérations de qualité structurées appropriées. Utiliser les connaissances pour améliorer l'efficacité opérationnelle.

Interagir directement avec Santé Canada ou d'autres autorités réglementaires et assurer une représentation adéquate de Moderna dans les questions liées à la conformité et à la qualité, surtout dans les communications avec les autorités sanitaires. Assurer la préparation à l'inspection et fournir des conseils et un soutien relatif aux Bonnes Pratiques de Fabrication (GMP).

Voici Ce Dont Vous Aurez Besoin (Qualifications Minimales)

Diplôme de baccalauréat dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, etc.) ou combinaison équivalente d'éducation et d'expérience

8 à 10 ans ou plus d'expérience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles

Capacité démontrée à prendre des décisions basées sur le risque

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
Fa

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