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Quality Assurance Manager
3 months ago
At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto's Top Employer 2024. Click here ) to find out why Gilead Sciences Canada is a top employer
Chez Gilead Sciences Canada Inc., nous sommes fiers d'être reconnus comme l'un des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour ) en savoir plus sur les raisons de notre succès.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Key responsibilities include :
- Release Kite products imported for distribution in Canada
- Oversee all aspects and execution related to product complaint management for Canadian product complaints that includes review and approval of investigations
- Review and approve Annual Product Reports
- Compile, review and approve Yearly Biologic Product Reports and coordinate submissions of reports to Health Canada
- Support activities associated with the maintenance of Drug Establishment Licence for Kite imported products that includes foreign buildings involved in licensable activities
- Perform Importer quality product annual lifecycle activities such as batch records and ongoing stability reviews
- Initiate, review, approve, as applicable change control and deviation quality records
- Oversee quality management system for importer/distributor regulatory requirements that may include maintenance and implementation of standard operating procedures to comply with Health Canada regulatory requirements and Kite expectations
- Perform selection audits and qualify and monitor apheresis and treatment centers (ATCs) to qualification requirements.
- Assist in the management of ATCs that includes training and changes management.
- Support inspection readiness plans and participates in audits and inspections
- Works collaboratively with Gilead/Kite team in Quality, Regulatory Affairs, Supply Chain, Manufacturing and Commercial organizations to effectively execute tasks and to participate in projects representing Gilead Canada affiliate
- Ability to travel up to 30% in Canada
- Identify and implement defined goals and objectives aligned with Gilead/Kite strategic initiatives
- Perform other duties as assigned
Knowledge, Experience and Skills
- Bachelor's degree in Life Sciences, Engineering or equivalent
- Minimum 6 years of pharmaceutical quality experience in a manufacturing or import/distribution settings; biological drug product experience is preferred
- Excellent communication and presentation skills with bilingual proficiency (French and English) is a requirement
- Comprehensive knowledge of QA systems, manufacturing and testing processes and related regulatory requirements including Health Canada Good Manufacturing Practices
- Ability to adapt to change to meet objective / deadlines and business priorities
- Ability to work with a high level of integrity, accuracy, and attention to detail to consistently meet high standards required in compliance
- Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments
- Excellent judgement and personal initiative
- Ability to work alone and in cross functional teams
- Demonstrates excellent verbal, written, and interpersonal communication skills
Kite, une société Gilead
Chez Kite, nous sommes à la pointe de l'immunothérapie et de la thérapie par cellules T artificielles. Nous contribuons à changer le paradigme du traitement du cancer et nous révolutionnons les traitements personnalisés. Cela signifie un environnement en évolution rapide et en constante évolution, dans lequel nous faisons des découvertes chaque jour – des découvertes qui incluent nos propres capacités et notre potentiel individuel.
Nous recherchons actuellement un Manager Assurance Qualité pour nous rejoindre et faire partie de notre passionnant voyage dans le développement d'immunothérapies anticancéreuses innovantes et leur application dans le traitement des patients atteints de cancer.
Faisant partie de l'équipe d'Assurance Qualité de la filiale de Gilead Sciences Canada, ce poste sera chargé de soutenir les activités de qualité et de conformité réglementaire au Canada.
Il s'agit d'un poste à distance qui peut être basé n'importe où au Canada, de préférence au Québec ou en Ontario.
Les principales responsabilités comprennent :
- Libérer les produits Kite importés pour distribution au Canada
- Superviser tous les aspects et l'exécution liés à la gestion des plaintes relatives aux produits canadiens, y compris l'examen et l'approbation des enquêtes.
- Examiner et approuver les rapports annuels sur les produits
- Compiler, examiner et approuver les rapports annuels sur les produits biologiques et coordonner la soumission des rapports à Santé Canada.
- Soutenir les activités associées au maintien de la licence des établissements de produits pharmaceutiques pour les produits importés par Kite.
- Effectuer les activités du cycle de vie annuel des produits importés, telles que les enregistrements de lots et les examens continus de la stabilité.
- Initier, examiner, approuver, le cas échéant, les enregistrements de contrôle des changements et de qualité des écarts.
- Superviser le système de gestion de la qualité pour les exigences réglementaires des importateurs/distributeurs qui peuvent inclure le maintien et la mise en œuvre de procédures opérationnelles standard pour se conformer aux exigences réglementaires de Santé Canada et aux attentes de Kite. Effectuer des audits de sélection et qualifier et surveiller les centres d'aphérèse et de traitement (ATC) selon les exigences de qualification.
- Aider à la gestion des ATC qui comprend la formation et la gestion des changements.
- Soutenir les plans de préparation aux inspections et participer aux audits et aux inspections.
- Travailler en collaboration avec l'équipe Gilead/Kite des organisations de qualité, d'affaires réglementaires, de chaîne d'approvisionnement, de fabrication et commerciale pour exécuter efficacement les tâches et participer aux projets représentant la filiale de Gilead Canada.
- Prévoir des déplacements jusqu'à 30 % au Canada.
- Identifier et mettre en œuvre les objectifs définis alignés sur les initiatives stratégiques de Gilead/Kite.
Connaissances, expérience et compétences
- Baccalauréat en sciences de la vie, en ingénierie ou équivalent.
- Min. 6 ans d'expérience en qualité pharmaceutique dans un contexte de fabrication ou d'importation/distribution ; une expérience en produits pharmaceutiques biologiques est préférable.
- Excellente communication avec une maîtrise bilingue du français et de l'anglais.
- Connaissance approfondie des systèmes d'assurance qualité, des processus de fabrication et d'essai et des exigences réglementaires, y compris les bonnes pratiques de fabrication de Santé Canada.
- Capacité à s'adapter au changement pour respecter les objectifs/délais et les priorités commerciales.
- Capacité à travailler avec un haut niveau d'intégrité, de précision et d'attention aux détails pour répondre systématiquement aux normes élevées requises en matière de conformité
- Solides compétences organisationnelles.
- Capacité à travailler seul et au sein d'équipes matricielles.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
