Superviseur, système qualité & conformité - Matériaux / QS&C Supervisor Materials

Grifols; Montreal; On-site; CAD 70,000 - 90,000; Full time

Job summary

Une entreprise mondiale de soins de santé cherche un(e) Superviseur(e) des Systèmes de Qualité et de Conformité à Montréal. Vous superviserez une équipe responsable de l'évaluation des matériaux et des fournisseurs. Les candidats doivent avoir un diplôme en STEM et au moins 5 ans d'expérience dans un domaine pertinent. Une maîtrise du français et de l'anglais est requise. Un environnement dynamique vous attend.

Qualifications

• 5 ans d'expérience dans un domaine pertinent ou équivalent.
• Bilinguisme en français et anglais.
• Expérience dans la gestion de la qualité et la qualification des fournisseurs.

Responsibilities

• Superviser l'évaluation des matériaux et des fournisseurs.
• Mener des audits internes et externes.
• Fournir une expertise technique sur les questions de qualité.

Skills

Gestion de projet

Gestion de la qualité

Communication

Certification GMP

Audits qualité

Education

BA / BS en STEM

Tools

SAP

Logiciels de gestion qualité

Job description

Résumé

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.

Summary: Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Job Title : Quality System and Compliance Supervisor – Materials and Suppliers

Reports to : Quality System and Compliance Manager

Summary :

Responsible for supervising or overseeing a group of employees and leading projects, particularly those in charge of evaluating materials and suppliers in the Quality Compliance Department. Participates in employee relations matters and is responsible for performance management in 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.

Primary responsibilities for role :

• 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.
• Supervise the evaluation of materials and suppliers.
• 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.
• Follows cGMP and department safety practices.
• Provides effective leadership to employees in Quality.
• 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.

In addition to the duties described above the Supervisor Quality System & Compliance may also perform the following duties based upon the business unit to which he / she is assigned :

• Assess and qualify new suppliers based on quality, compliance, and performance criteria.
• Conduct audits and risk assessments of suppliers.
• Maintain an approved supplier list and ensure ongoing compliance.
• Lead / participate in internal, external, and supplier compliance audits.
• Lead / participate in supplier quality audits.
• Assist in the facilitation and hosting of site regulatory inspections and customer audits.
• Review and approve raw materials, components, and packaging materials.
• Ensure materials meet specifications, regulatory requirements, and internal standards.
• Investigate and resolve material-related quality issues.
• Prepare, review, and / or approve validation and / or engineering documents.
• Review and analyze data, prepare and review reports (example : Quality Metrics, ...).
• Participate in, review, and / or approve failure investigations. Author, edit, and / or publish SOPs, Specifications, and other documents.
• Plan, schedule and execute routine and directed internal audits and follow-up on observations from previous audits.
• Revise, negotiate, and complete Quality Agreements, Manufacturing Agreements and Confidentiality Agreements with suppliers, customers and distributors.
• Collaborate with manufacturing, QC and other departments on projects, deviation investigations, CAPAs, change controls, for improvement of Quality Systems, etc.
• Play include roles such as author, reviewer / approver, administrator or coordinator in the quality systems such as Change Control, Deviation Management, CAPA, SAP, SAP Quality Module, Documentation.
• Responsible for representing Quality at business unit meetings, and project meetings.

Qualifications :

• BA / BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience.
• Experience managing, leading, and coaching employees, projects, teams, etc. is recommended.
• Demonstrated experience in Quality Systems.
• Experience with supplier quality management and material qualification.
• Has excellent communication skills (written and verbal) with demonstrated use of domestic Health Canada and applicable foreign regulatory agency requirements / guidelines (e.g., FDA CFR).
• Demonstrates high levels of value and integrity.
• Bilingual in French and English (English proficiency required to ensure exchanges of documentation and communications with other Grifols sites outside Quebec and Canada (Spain, USA)).

Location : NORTH AMERICA : Canada : Montreal || NORTH AMERICA : Canada : QC-Quebec : CAQUEBEC - Quebec

Notes / Disclaimer

This description includes content in both French and English to reflect the original posting. This document is for internal review and refinement and preserves the original responsibilities and qualifications.