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Supervisor, Quality System and Compliance

5 months ago

Montréal, Canada G Canada Therapeutics Full time

¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones.

**Position Title: Supervisor, Quality System & Compliance**

**Reports to: Senior Quality Assurance and Compliance Manager**

**Position Summary**:
The Supervisor Quality System and Compliance is responsible for supervision and oversees a group of employees including leading projects and other files in the Quality Compliance Department. Participates in employee relation matters and is responsible for performance management in the area of responsibility. May facilitate technical and non-technical training. Is expected to gather the necessary research and data for substantiated proposals to area management. May perform other duties as assigned.

**Key Duties and Responsibilities**
- May lead a Quality system, program, or project.
- Supervise or oversee all aspects of a group of employees and/or a Quality system, program, or project.
- Ensures compliance with company policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
- Provides technical / non-technical expertise on quality related matters.
- Provides guidance or may consult with manufacturing and internal regulatory departments on GXP matters.
- Has excellent communication skills (written and verbal) with with demonstrated use of domestic (i.e. Health Canada) and applicable foreign regulatory agency requirements/guidelines (i.e. Food and Drug Administration CFR).
- Follows cGMP and department safety practices.
- Provides effective leadership to employees in Quality.
- Demonstrated experience in Quality Systems.
- Demonstrates high levels of value and integrity.
- May consult with and make proposals to Quality Sr. Management regarding key decisions which need to be made within his/her defined area of responsibility.
- May also lead/participate in internal, external, and supplier compliance audits. Lead/participate in supplier quality audits.
- May assist in the facilitation and hosting of site regulatory inspections and customer audits.
- May prepare, review, and/or approve validation and/or engineering documents. Review and analyze data, prepare and review reports (example: Quality Metrics, etc...).
- May perform other tasks related to the position.

**Qualifications requried**:

- BA or Sc in a Life Sciences or relevant degree with minimum of 5 years relevant experience. MSc in a Life Sciences or relevant degree with minimum of 3 years relevant experience.
- Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 5 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 3 years of experience.
- Experience in managing, leading and coaching employees, projects, teams is preferable.
- Excellent communication skills (written and verbal) with familiarity in domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements (guidelines (i.e. Eudralex, POIC/s, Health Canada.
- Proficiency with Microsoft office including Word, Excel, and PowerPoint.
- Bilingual in both French and English preferred.

**Titre du poste : Superviseur, système qualité et conformité**

**Relève de : Directeur principal, assurance qualité et conformité**

**Résumé du poste**:
Le superviseur, système qualité et conformité est responsable de la supervision de l’équipe du département incluant la direction de projets et autres dossiers au sein du Service. Participe aux questions relations en relations avec les employés et est responsable de la gestion du rendement dans le secteur sous sa responsabilité. Participe à la formation technique. Doit rassembler les données nécessaires pour des propositions étayées à la direction du département. Peut effectuer d’autres tâches assignées.

**Principales tâches et responsabilités**
- Peut diriger un projet ou un programme d’un système qualité ;
- Supervise un groupe d’employés et/ou les aspects d’un programme/d’un système qualité ;
- Assure le respect des politiques et procédures de l’entreprise et est responsable de l’utilisation optimale du personnel et des capacités techniques dans des domaines définis ;
- Fournit une expertise technique/non-technique sur les questions liées à la qualité ;
- Fournit des cons