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Gestionnaire de la conformité / Compliance Manager (Banff)

Knight Therapeutics Canada

Thérapeutique Knight est à la recherche d’un(e) gestionnaire de la conformité responsable de superviser l’ensemble des activités de conformité au Canada.

À propos du poste

Ce poste combine un rôle de conseil et opérationnel, afin de garantir que le programme de conformité de Knight est efficacement mis en œuvre, suivi et continuellement amélioré, avec un fort alignement entre les normes globales et leur application locale. Le rôle agit comme un leader clé de la conformité pour l’organisation canadienne, en veillant à la préparation aux audits, à la prévention des risques et à l’excellence des processus de conformité.

Responsabilités principales

  • Agir à titre de principal responsable de la conformité pour le Canada, en soutien aux différentes équipes internes (marketing, médicales, commerciales ou autres).
  • Servir de conseiller de confiance en matière de politiques de conformité, de Code de conduite, de KWI, du Code IMC et des exigences réglementaires applicables.
  • Diriger le processus de révision et d’approbation du matériel promotionnel, des interactions avec les professionnels de la santé, des événements, contrats, commandites, dons et engagements avec des tiers, incluant la supervision des approbations dans Veeva.
  • Soutenir les enquêtes internes, la résolution des enjeux et les initiatives de remédiation en collaboration avec les équipes juridiques et des ressources humaines.
  • Superviser la mise en œuvre des programmes de formation obligatoires en conformité au Canada, en assurant leur efficacité et leur niveau d’engagement.
  • Piloter les communications en conformité, les initiatives de sensibilisation ainsi que les efforts favorisant une culture d’intégrité.
  • Analyser les résultats des activités de surveillance afin d’identifier les tendances, les causes et les risques, et veiller à l’escalade et à la mise en place de mesures correctives appropriées.
  • Assurer le suivi et la clôture en temps opportun des actions correctives et préventives (CAPA).
  • Assurer le suivi de la complétion des formations, de l’exactitude des données et des actions de suivi auprès des équipes concernées.
  • Maintenir une préparation continue aux audits en assurant une documentation robuste, une gestion adéquate des preuves et le respect des pratiques de conservation des dossiers.
  • Examiner les résultats d’audit et contribuer à l’élaboration et à la mise en œuvre des plans de remédiation.
  • Gérer les référentiels documentaires liés à la conformité, en assurant le contrôle des versions et l’accessibilité.
  • Fournir des directives claires aux équipes quant aux normes documentaires et aux pratiques de surveillance.
  • Identifier et mettre en œuvre des opportunités visant à améliorer, simplifier et renforcer les processus et outils de conformité, y compris l’utilisation de l’intelligence artificielle.
  • Collaborer avec les parties prenantes en conformité afin de favoriser la cohérence et le partage des meilleures pratiques au sein de l’organisation.

Qualifications

  • Plus de 5 années d’expérience en conformité, contrôles internes, audit ou dans une fonction similaire au sein d’une entreprise pharmaceutique multinationale.
  • Excellentes compétences organisationnelles et en gestion documentaire.
  • Capacité à travailler avec des équipes réparties sur plusieurs fuseaux horaires, cultures et unités d’affaires.
  • Bilinguisme (français et anglais) avec d’excellentes habiletés de communication.

Thérapeutique Knight s'engage à offrir un environnement de travail francophone à tous ses employés basés au Québec. Toutefois, malgré ses efforts déployés dans le cadre de son programme de francisation pour limiter l’exigence de l’anglais, la maîtrise de l'anglais pour ce poste est de niveau avancé, notamment en raison de la nécessité de collaborer régulièrement avec une équipe multidisciplinaire située à l’extérieur du Québec, dont la langue de travail est l’anglais. La maîtrise de l’anglais est donc essentielle pour assurer une communication efficace et la réalisation des tâches liées au poste.

About the role

Knight Therapeutics is seeking a Compliance Manager responsible for overseeing all Compliance activities in Canada.

Key Responsibilities

  • Act as the primary Compliance lead for Canada, supporting various internal teams (marketing, medical, commercial, and others).
  • Serve as a trusted advisor on compliance policies, the Code of Conduct, KWI, IMC Code, and applicable regulatory requirements.
  • Lead the review and approval process for promotional materials, HCP interactions, events, contracts, sponsorships, donations, and third-party engagements, including oversight of Veeva approvals.
  • Support internal investigations, issue resolution, and remediation initiatives in collaboration with Legal and HR.
  • Oversee the implementation of mandatory compliance training programs in Canada, ensuring effectiveness and engagement.
  • Drive compliance communications, awareness initiatives, and efforts that promote a culture of integrity.
  • Analyze monitoring outputs to identify trends, root causes, and risks, ensuring appropriate escalation and corrective actions.
  • Ensure timely tracking and closure of corrective and preventive actions (CAPAs).
  • Monitor training completion, data accuracy, and follow-up actions with relevant teams.
  • Maintain ongoing audit readiness by ensuring robust documentation, evidence management, and record retention practices.
  • Review audit outcomes and contribute to the development and execution of remediation plans.
  • Manage compliance documentation repositories, ensuring proper version control and accessibility.
  • Provide clear guidance to teams on documentation standards and monitoring practices.
  • Identify and implement opportunities to enhance, streamline, and strengthen compliance processes and tools, including the use of AI.
  • Partner with Compliance stakeholders to promote consistency and best practices across the organization.

Qualifications

  • 5+ years of experience in compliance, internal controls, audit, or a similar function within a multinational pharmaceutical company.
  • Excellent organizational and documentation management skills.
  • Ability to work across multiple time zones, cultures, and business units.
  • Bilingualism (French and English) with excellent communication skills.
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