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: Quality Assurance Supervisor

Reports to: Senior Quality Director

Position Summary:

The Supervisor is responsible for the development and direct supervision of the Quality assurance Department, demonstrate consistent application of technical knowledge and ensures that the Company\'s quality operations objectives are achieved., provides guidance and requirements for changes; oversees the Quality operation (related to manufacturing and quality Control Laboratory) of a Quality Assurance business unit within QA Supply Chain, Product Quality Management and Audits.

Key Duties and Responsibilities

• Supervise all aspects of a Quality Assurance Operations business unit (documentation, laboratory operations, employee relations, etc.).
• Provide guidance as well as consult with manufacturing and internal regulatory departments on GXP matters.
• Use expertise and sound judgment to make independent decisions within defined areas of responsibility.
• Plan and analyze workflow, delegate, and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget.
• Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements.
• Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.
• Supervise and Provide guidance and scientific/technical advice regarding validations and validation deviations and all deviations related to operations (Manufacturing and Quality control).
• Review and approve technical protocols and reports including stability, characterization, and validation studies.
• Review and revise Standard Operating Procedures and generate reports.
• Investigate and initiate corrective action places for quality related issues.
• Maintain current knowledge of Health Canada, FDA, EU and other regulatory agencies and industry standards.
• Communicate with cross functional departments and support groups to improve departmental performance and efficiency.
• Provide support, direction and coaching to subordinate employees in the areas of the Quality Assurance department.
• Communicate effectively and promptly at all levels of the organization .

May perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and PQM on projects, incident investigations, and annual product reviews. Prepare, review, and/or approve validation and/or engineering documents.

Qualifications required :

• BSc 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.
• Excellent communication skills (written and verbal).
• Extensive working knowledge of domestic (i.e. Health Canada) and applicable foreign regulatory agency requirements/guidelines (i.e. Food and Drug Administration)
• Proficiency with Microsoft office including Word, Excel, and PowerPoint.
• Bilingual in both French and English preferred.

Titre du poste : Superviseur de l\'assurance de la qualit\xc3\xa9Rel\xc3\xa8ve de : Directeur principal de la qualit\xc3\xa9

R\xc3\xa9sum\xc3\xa9 du poste :

Le superviseur est responsable du d\xc3\xa9veloppement et de la supervision directe de l.

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

• Supervise tous les aspects d\'une unit\xc3\xa9 op\xc3\xa9rationnelle des op\xc3\xa9rations d\'assurance de la qualit\xc3\xa9 (documentation, op\xc3\xa9rations de laboratoire, relations avec les employ\xc3\xa9s, etc.) ;
• Fournit des conseils ainsi que des consultations avec les services de fabrication et de r\xc3\xa9glementation interne sur les questions GXP ;
• Fait appel \xc3\xa0 son expertise et \xc3\xa0 son bon jugement pour prendre des d\xc3\xa9cisions ind\xc3\xa9pendantes dans des domaines de responsabilit\xc3\xa9 d\xc3\xa9finis ;
• Planifie et analyse le flux de travail, d\xc3\xa9l\xc3\xa8gue et \xc3\xa9tablit les priorit\xc3\xa9s, pour s\'assurer que les affectations et les projets sont achev\xc3\xa9s en temps opportun et dans les limites du budget pr\xc3\xa9vu ;
• \xc3\x89value et estime les contr\xc3\xb4les de changements pour d\xc3\xa9terminer les exigences qui s\'appliquent et aider \xc3\xa0 d\xc3\xa9terminer la classification et les exigences r\xc3\xa9glementaires en termes de rapports ;
• Participe aux inspections r\xc3\xa9glementaires/audits internes, y compris les discussions directes avec les auditeurs et fournit des r\xc3\xa9ponses \xc3\xa9crites, le cas \xc3\xa9ch\xc3\xa9ant, selon le champ de responsabilit\xc3\xa9 ;
• Supervise et fournit des conseils et des conseils scientifiques et techniques concernant les validations, les \xc3\xa9carts de validation et tous les \xc3\xa9carts li\xc3\xa9s aux op\xc3\xa9rations (fabrication et contr\xc3\xb4le qualit\xc3\xa9) ;
• Examine et approuve les protocoles et les rapports techniques, y compris les \xc3\xa9tudes de stabilit\xc3\xa9, de caract\xc3\xa9risation et de validation ;

connexes ; * Enqu\xc3\xaate et initie des actions correctives pour les probl\xc3\xa8mes li\xc3\xa9s \xc3\xa0 la qualit\xc3\xa9 ;

• Maintient une connaissance \xc3\xa0 jour de Sant\xc3\xa9 Canada, de la FDA, de l\'UE et autres organismes de r\xc3\xa9glementation et des normes de l\'industrie ;
• Communique avec les d\xc3\xa9partements interfonctionnels et les groupes de soutien pour am\xc3\xa9liorer les performances et l\'efficacit\xc3\xa9 du d\xc3\xa9partement ;
• Fournit un soutien, une orientation et un encadrement aux employ\xc3\xa9s subalternes dans les domaines du service d\'assurance de la qualit\xc3\xa9 ;
• Communique efficacement et rapidement \xc3\xa0 tous les niveaux de l\'organisation ;

de laboratoire. Collaborer avec la production et PQM sur les projets, les enqu\xc3\xaates sur les incidents et les examens annuels des produits. Pr\xc3\xa9parer, examiner et/ou approuver des documents de validation et/ou d\'ing\xc3\xa9nierie.

Qualifications requried :

• BSc en sciences de la vie ou dipl\xc3\xb4me pertinent avec un minimum de 5 ans d\'exp\xc3\xa9rience dans le domaine, MSc en sciences de la vie ou dipl\xc3\xb4me pertinent avec un minimum de 3 ans d\'exp\xc3\xa9rience pertinente ;
• Selon le domaine d\'affectation, une exp\xc3\xa9rience directement li\xc3\xa9e ou une combinaison d\'\xc3\xa9tudes et d\'exp\xc3\xa9rience et/ou de comp\xc3\xa9tences directement li\xc3\xa9es peut \xc3\xaatre consid\xc3\xa9r\xc3\xa9e \xc3\xa0 la place des exigences \xc3\xa9nonc\xc3\xa9es. Exemple : Si un niveau d\'emploi n\xc3\xa9cessite un baccalaur\xc3\xa9at plus 5 ans d\'exp\xc3\xa9rience, une \xc3\xa9quivalence pourrait inclure 8 ans d\'exp\xc3\xa9rience, un dipl\xc3\xb4me d\'associ\xc3\xa9 avec 6 ans d\'exp\xc3\xa9rience ou une ma\xc3\xaetrise avec 3 ans d\'exp\xc3\xa9rience ;
• Excellentes comp\xc3\xa9tences en communication (\xc3\xa9crite et verbale) ;
• Connaissance pratique approfondie des exigences et des lignes directrices des organismes de r\xc3\xa9glementation nationaux (p.e. Sant\xc3\xa9 Canada) et \xc3\xa9trangers applicables (p.e. la Food and Drug Administration) ;
• Exp\xc3\xa9rience en interaction lors d\'enqu\xc3\xaates des organismes de r\xc3\xa9glementation ;
• Ma\xc3\xaetrise de Microsoft Office, y compris Word, Excel et PowerPoint.
• Bilingue en fran\xc3\xa7ais et en anglais de pr\xc3\xa9f\xc3\xa9rence.

Grifols