GCP Senior QA

hace 4 semanas

Barcelona, España LEO Pharma A tiempo completo
Your role
Main responsibilities
  • Perform audits worldwide for clinical trials within the GCP/GCLP area
    • including explorative trials, Phase I-IV trials, suppliers, CROs, central laboratories, special laboratories, vendors, and internal GCP systems and processes
  • Process Owner delegate of the GCP Inspection process  
    • developing the LEO Pharma GCP inspection process
    • co-host and operate the GCP inspection process driving preparations, execution and follow-up activities

Secondary responsibilities

  • Provide quality expertise and advice to stakeholders on complex matters related to GCP
  • Subject matter expert within GCP area with focus on how relevant regulations impact the quality level of clinical trials within the GCP area
  • Participate in defining the audit strategy including risk assessment, and ensuring oversight and trending of the audit program for clinical trials within the GCP/GCLP area

 

You will be an important contributor and driver of improvement activities within the GCP Quality areas. You may also be involved in due diligence during acquisitions.

In this role you will have approximately 30-50 travel days related to audits in Europe, Americas, and Asia.

 

Your qualifications 
To succeed in this role, we imagine that you have the following qualifications:

  • Master's degree in a relevant field (e.g., Life Sciences, Pharmacy, etc.).
  • Solid experience within a GCP regulated area 
  • Extensive experience (minimum 5-7 years years) in GCP auditing e.g. CROs, central- and special- laboratories, suppliers, and internal GCP systems and processes.

Preferred qualification

  • Experience with Authority Inspections
  • Experience in developing and implementing quality processes
  • Solid experience within a GCP regulated area 
  • Strong knowledge within clinical drug development activities, clinical operations, and data management and IT system validation and security
  • Strong expertise in Quality Management Systems and risk assessment methodologies

 

As our ideal candidate, you are a team player with excellent interpersonal and networking skills. You value knowledge sharing and work effectively with others to achieve team goals. 

You have a strong understanding of fundamental business processes and their interactions, including the impact of external/internal influences on decision-making. As a self-starting and highly structured individual, you plan your own work and deliver on time. 

Joining our team offers a unique opportunity for personal and professional growth, allowing you to contribute to critical business processes.

 

Your new team
R&D Quality, that is part of the Corporate Quality area in the Global Quality organization, is responsible for ensuring quality in R&D activities across the entire LEO Pharma organization in RA, Safety, CMC, Clinical Operation and Development, Medical Device, and DDC, including GCP.

 

You will join 15 enthusiastic and very experienced colleagues – we are auditors, qualified persons and specialists within the field of responsibility of R&D Quality. 
 
Quality is in our DNA, and we strive to challenge and drive the quality path forward for the success of LEO Pharma. Our team always considers processes from end to end and values input from others.

In our informal work environment, everyone's voice is heard. We aspire to execute with excellence, be professional and ambitious, and never forget to have fun

 

  • Senior QA Automation Tester

    hace 7 días

    Barcelona, España Kapres Technology, S.L. A tiempo completo

    Desde Kapres Technology estamos buscando a un/a **Senior QA Automation Tester** para un proyecto internacional en un importante cliente del sector seguros, trabajo 100% remoto (alguna vez iras a conocer al equipo, a Barcelona, pero es en remoto), puesto estable de larga duración. Necesitamos siguiente perfil: **Senior QA Automation...

  • Senior Qa Automation Tester

    hace 4 semanas

    Barcelona, España Kaprestechnology A tiempo completo

    Desde Kapres Technology estamos buscando a un/a Senior QA Automation Tester para un proyecto internacional en un importante cliente del sector seguros, trabajo 100% remoto (alguna vez iras a conocer al equipo, a Barcelona, pero es en remoto), puesto estable de larga duración. Necesitamos siguiente perfil: Senior QA Automation Tester Description: o QA vision...

  • Senior QA Automator

    hace 4 semanas

    Barcelona, España Kapres Technology, S.L. A tiempo completo

    Para un importante cliente del sector seguros, Necesitamos **SENIOR QA AUTOMATOR, el trabajo es 100% remoto.**(Alguna vez hay que ir a las oficinas en Cornellá, Barcelona) **Mission**: Provide the means and the measures for designing and developing all the quality aspects of a software solution, both functionally and technically, in order to meet the...

  • Senior Qa Engineer

    hace 2 semanas

    Barcelona, España Sita A tiempo completo

    OverviewLocation: Barcelona, Spain Schedule: Full-time Start date: to be agreed. Ready to redefine air travel? The journey starts here, with you at SITA. ABOUT THE ROLE & TEAM: Our Senior QA Engineer with a focus on automation, will be a key pillar in SITA's contribution to a greener, more sustainable aviation through the enablement of flight and air traffic...

  • QA Auto

    hace 4 semanas

    Barcelona, España Oxigent A tiempo completo

    ¿Te interesa desarrollarte como QA Tester - Automatización en un entorno internacional donde trabajarás con metodologías Agile? Desde Oxigent Technologies seleccionamos un perfil QA AUTOMATION para participar en un proyecto a largo plazo, siendo parte de un equipo de desarrollo web y mobile dentro de una empresa multinacional en el sector transporte,...

  • Senior QA Lead

    hace 2 semanas

    Barcelona, España Scopely A tiempo completo

    Description Scopely is looking for a Senior QA Lead for our unannounced project in Barcelona on a hybrid basis working from the hub. We can support with visa sponsorship and relocation assistance. At Scopely, we care deeply about what we do and want to inspire play, every day - whether in our work environments alongside our talented colleagues, or...

  • Senior QA Engineer

    hace 4 semanas

    Barcelona, España Codurance A tiempo completo

    Codurance is a high-end IT consultancy born in the UK 10 years ago and our main goal is to raise the bar in the software industry through professionalism and technical excellence! As a **Senior QA Engineer** at Codurance, you will be working closely with the client and our craftspeople, making sure our products and procedures meet safety and quality...

  • Head Of Qa

    hace 3 semanas

    Barcelona, España Sdi Digital Group A tiempo completo

    Our opportunity In this role you'll be responsible for managing the QA team to effectively perform, monitor, and report Test and QA results to business stakeholders and senior management. You will also be responsible for building and running test automation for our Flutter App. Reporting into the Chief Technology Officer, you will work as part of our...

  • Graduate QA

    hace 7 días

    Barcelona, España Sage Group PLC A tiempo completo

    **Nombre de vacante** - Graduate QA **Descripción** - Location Barcelona Intake: January 2023 Passionate and hungry to learn new skills and technologies? you are known for your great problem solver skills? Your enthusiasm, your analytical skills, creativity, and your team player spirit will be the key to succeed on this position. If you also appreciate to...

  • Head Of Qa

    hace 2 semanas

    Barcelona, España Sdi Digital Group A tiempo completo

    Our opportunity In this role you'll be responsible for managing the QA team to effectively perform, monitor, and report Test and QA results to business stakeholders and senior management. You will also be responsible for building and running test automation for our Flutter App. Reporting into the Chief Technology Officer, you will work as part of our...

  • Head Of Qa

    hace 2 semanas

    Barcelona, España Zurich Insurance A tiempo completo

    Our opportunityIn this role you'll be responsible for managing the QA team to effectively perform, monitor, and report Test and QA results to business stakeholders and senior management.You will also be responsible for building and running test automation for our Flutter App.Reporting into the Chief Technology Officer, you will work as part of our...

  • Senior QA Automation

    hace 4 semanas

    Barcelona, España Freightos A tiempo completo

    **About The Position**: WebCargo digitizes global freight sales for over 2,000 of the world’s largest logistics providers and carriers. Or, in plain English, we help move the world, offering incredible technology that powers almost a third of the global air cargo market. We’re not alone either. WebCargo is a proud part of the Freightos Group, a...

  • Senior QA Tester

    hace 4 semanas

    Barcelona, España Emprego ES A tiempo completo

    2 years of experience in the gaming industry Knowledge of Debug, Documentation and CI / CD tools and technologies, including but not limited to Jenkins, XCode, Android Studio, adb, Kibana, JIRA, Confluence Comprehensive understanding of how bugs are reported for the dev team to fix Experience using automation tools for QA testing (not necessarily...

  • Senior Devops Engineer

    hace 4 semanas

    Barcelona, España Eurofins A tiempo completo

    Job Description In a nutshell As a Senior Devops Engineer, you will join a challenging and unique large-scale Transformation Program with high impact and visibility. Your primary focus will be the engineering, configuration, installation, and maintenance of public and private cloud, Linux OS and CI/CD; in addition to code maintenance.  Where...

  • Director PMO

    hace 5 días

    Barcelona, España ADP A tiempo completo

    **Director CSL Implementation - PMO & QA** Role objectives: As a member of ADP's CSL Implementation Senior Leadership team, the Director CSL Implementation - Project Management Office (PMO) & Quality Assurance (QA), has global responsibility to bring global alignment and consistency of project delivery, supporting the development of a high performing and...

  • Senior QA Engineer

    hace 7 días

    Barcelona, España Freightos A tiempo completo

    **About The Position**: WebCargo digitizes global freight sales for over 2,000 of the world’s largest logistics providers and carriers. Or, in plain English, we help move the world, offering incredible technology that powers almost a third of the global air cargo market. We’re not alone either. WebCargo is a proud part of the Freightos Group, a...

  • QA Senior Automation Platform Engineer

    hace 6 días

    Barcelona, España Quantion A tiempo completo

    **Who we are**: Quantion is a Business Digital Transformation services company born in 2015. Our services are based on a Digital Factory model. Through this model we help companies to accelerate its digital transformation projects with an end-to-end approach. As a Digital Factory we combine our teams in cutting-edge technologies and digital deep...

  • Senior QA Engineer

    hace 1 mes

    Barcelona, España AgileEngine A tiempo completo

    **What you will do** - Write, review and execute test cases/suits throughout the development life cycle; - Ensure test cases/suits thoroughly cover all requirements and use cases; - Actively participate in grooming sessions of the scrum team, provide feedback from the end-user perspective; - Closely work with QAs from all teams on common topics; - Foster a...

  • Mobile QA Engineer

    hace 4 semanas

    Barcelona, España Tripledot Studios A tiempo completo

    Job reference - F6DB7E7E30 - Company Name - Tripledot Studios - Salary - Competitive - Location - Barcelona, Spain - Country - Spain - Industry sector - QA - Job start date - ASAP - Posted date - 23/02/2023 - Experience Level - Mid-Senior Level - Job type - Permanent | Full Time - Remote / Hybrid - No **About the Company** We are a rapidly growing mobile...

  • Senior Etl Developer

    hace 3 días

    Barcelona, España Next-Link A tiempo completo

    Job Description We are seeking a highly motivated Senior ETL Developer to join the Operations & Laboratories team and play a key role supporting a major pharmaceutical client. What You'll Do: - Restructure & improve the existing ETL pipeline & develop new ETL pipeline - Writing of Unit Test according best practices Writing of Acceptance (Integration) test -...