Job Description

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Position Title : Manager, Quality Assurance

Reports to: Sr Manager, Quality Assurance/Quality Systems & Compliance

Position Summary:

The Manager, Quality Assurance manages the QA Department. Develops processes and procedures to ensure that appropriate regulatory requirements are respected. The Manager is responsible for development and direct supervision of the QA Department and ensures that the Company\'s Quality Program\'s objectives are achieved. Reviews regulatory submissions to Health Canada, USA FDA, EU, and other markets, provides guidance on submission classification and requirements for major changes. Provides responses as applicable for regulatory and internal audits; reviews/approves technical documents, including validation reports and R&D characterization and stability reports.

Key Duties and Responsibilities

Oversee and manage the QA Department and provide support, direction and coaching to team members.

Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements.

Interface with various groups to ensure that content in complex technical submissions and information requests to Health Canada, FDA and other regulatory agencies is accurate and complete.

Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.

Provide guidance and scientific/technical advice regarding validations and validation deviations as needed.

Review and approve technical protocols and reports including stability, characterization and validation studies.

Author and/or edit Standard Operation Procedures (SOPs), License Specifications (LSs), risk assessments, regulatory submissions and other documents.

Maintain current knowledge of FDA, EU and other regulatory agencies and industry standards.

Communicate with cross functional departments and support groups to improve departmental performance and efficiency.

Practice high level of facilitations skills to reach consensus and works toward solutions.

Identify, drive and implement process and system improvements.

Develop metric and benchmarking reports for presentation to top management. Proactively evaluate systems for trends and adverse findings. Identify, drive and implement improvements that result in sustainable compliance.

Qualifications required:

10 years of professional experience in pharmaceutical lab or manufacturing areas which include supervisory experience.

Excellent communication skills (written and verbal)

Extensive working knowledge of domestic (i.e. Health Canada) and applicable foreign regulatory agency requirements/guidelines (FDA)

Experience interacting with Regulatory Agency Investigations.

Proficiency with Microsoft office including Word, Excel and PowerPoint.

Bilingual in both French and English preferred.

Titre du poste : Gestionnaire, Assurance qualit\xc3\xa9

Superviseur : Gestionnaire principal, assurance qualit\xc3\xa9, syst\xc3\xa8mes et conformit\xc3\xa9

Sommaire du poste

Le Gestionnaire, Assurance qualit\xc3\xa9 est responsable de la gestion du D\xc3\xa9partement assurance qualit\xc3\xa9; d\xc3\xa9veloppe des proc\xc3\xa9d\xc3\xa9s et proc\xc3\xa9dures et veille \xc3\xa0 ce que exigences r\xc3\xa8glementaires en mati\xc3\xa8re d\'assurance qualit\xc3\xa9 soient respect\xc3\xa9s. Le gestionnaire est responsable du d\xc3\xa9veloppement et de la supervision de l\'\xc3\xa9quipe AQ et s\'assure que les objectifs du programme qualit\xc3\xa9 de la Soci\xc3\xa9t\xc3\xa9 soient atteints. Examine les soumissions r\xc3\xa9glementaires \xc3\xa0 Sant\xc3\xa9 Canada, \xc3\xa0 la FDA des \xc3\x89tats-Unis, \xc3\xa0 l\'UE et \xc3\xa0 d\'autres march\xc3\xa9s, fournit des directives sur la classification des soumissions et les exigences pour les changements majeurs. Fournit des r\xc3\xa9ponses, au besoin, pour les audits r\xc3\xa9glementaires et internes; revoit et approuve les documents techniques, y compris les rapports de validation et les rapports de caract\xc3\xa9risation et de stabilit\xc3\xa9 de la R&D.

Principales t\xc3\xa2ches et responsabilit\xc3\xa9s

• G\xc3\xa9rer et superviser tous les aspects des op\xc3\xa9rations d\'assurance qualit\xc3\xa9 du Service AQ et fournir le support, la direction et le coaching aux employ\xc3\xa9s de l\'\xc3\xa9quipe QA ;
• \xc3\x89valuer et \xc3\xa9valuer les contr\xc3\xb4les des changements afin de d\xc3\xa9terminer les exigences applicables et d\'aider \xc3\xa0 d\xc3\xa9terminer la classification et les exigences r\xc3\xa9glementaires en mati\xc3\xa8re de rapports ;
• Assurer l\'interface avec divers groupes pour s\'assurer que le contenu des pr\xc3\xa9sentations techniques complexes et des demandes de renseignements \xc3\xa0 Sant\xc3\xa9 Canada, \xc3\xa0 la FDA et \xc3\xa0 d\'autres organismes de r\xc3\xa9glementation soit exact et complet ;
• Participer aux inspections et aux v\xc3\xa9rifications r\xc3\xa9glementaires et internes, y compris des discussions directes avec les v\xc3\xa9rificateurs et fournir des r\xc3\xa9ponses \xc3\xa9crites, le cas \xc3\xa9ch\xc3\xa9ant, dans le domaine de responsabilit\xc3\xa9 ;
• Fournir une orientation et des conseils scientifiques et techniques concernant les validations et les \xc3\xa9carts de validation, au besoin ;
• Examiner et approuver les protocoles et les rapports techniques, y compris les \xc3\xa9tudes de stabilit\xc3\xa9, de caract\xc3\xa9risation et de validation ;
• R\xc3\xa9diger et/ou \xc3\xa9diter des proc\xc3\xa9dures d\'utilisation normalis\xc3\xa9es (SOPs), des sp\xc3\xa9cifications de licences, \xc3\xa9valuations de risques, soumissions r\xc3\xa9glementaires et autres documents ;
• Maintenir une connaissance \xc3\xa0 jour de la FDA, de l\'UE et d\'autres organismes de r\xc3\xa9glementation et normes de l\'industrie ;
• Communiquer avec les minist\xc3\xa8res inter-fonctionnels et les groupes de soutien pour am\xc3\xa9liorer la performance et l\'efficacit\xc3\xa9 du d\xc3\xa9partement ;
• Exercer un haut niveau de comp\xc3\xa9tences en facilitation pour parvenir \xc3\xa0 un consensus et travailler vers des solutions ;
• Identifier, piloter et mettre en \xc5\x93uvre des am\xc3\xa9liorations des processus et de syst\xc3\xa8mes ;
• \xc3\x89laborer des rapports de mesure et d\'analyse comparative pour pr\xc3\xa9senter \xc3\xa0 la direction. \xc3\x89valuer de mani\xc3\xa8re proactive les syst\xc3\xa8mes pour les tendances et les r\xc3\xa9sultats d\xc3\xa9favorables. Identifier, mener et mettre en \xc5\x93uvre des am\xc3\xa9liorations qui se traduisent par une conformit\xc3\xa9 durable.

Qualifications requises:

• Doctorat en sciences de la vie ou dipl\xc3\xb4me pertinent avec un minimum de 6 ans d\'exp\xc3\xa9rience pertinente. MSc dans un dipl\xc3\xb4me en sciences de la vie ou dipl\xc3\xb4me pertinent avec un minimum de 8 ans d\'exp\xc3\xa9rience pertinente. BSc dans un dipl\xc3\xb4me en sciences de la vie ou dipl\xc3\xb4me pertinent avec un minimum de 10 ans d\'exp\xc3\xa9rience pertinente ;
• 10 ans d\'exp\xc3\xa9rience professionnelle en labo pharmaceutique ou en environnement manufacturing incluant de l\'exp\xc3\xa9rience de supervision ;
• Excellentes comp\xc3\xa9tences en communication (\xc3\xa9crit et verbal)
• Connaissance pratique approfondie des exigences et des lignes directrices des organismes de r\xc3\xa9glementation nationaux (c.-\xc3\xa0-d. Sant\xc3\xa9 Canada) et \xc3\xa9trangers applicables (c.-\xc3\xa0-d. la Food and Drug Administration) ;
• Exp\xc3\xa9rience en termes d\'interactions efficaces lors de v\xc3\xa9rifications des Agences R\xc3\xa9glementaires ;
• Tr\xc3\xa8s bonne connaissance de la suite Microsoft Office incluant Word, Excel et PowerPoint ;
• Peut \xc3\xa9laborer et recommander avec la haute direction des objectifs financiers / budgets pour un seul
• Bilinguisme fran\xc3\xa7ais et anglais de pr\xc3\xa9f\xc3\xa9rence.

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

Grifols