Gvp Quality Assurance Senior Manager
hace 3 semanas
Overview:
Senior Manager, GVP Quality
at Kyowa Kirin International plc
Madrid, Spain or Marlow, UK
**WE PUSH THE BOUNDARIES OF MEDICINE.**
**LEAPING FORWARD TO MAKE PEOPLE SMILE**
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.
**Responsibilities**:
- Inspections performance.
**This role can be based in Spain, or UK**
- Provide input into and maintain the Strategy Document
- Perform annual risk assessment
- Develop, maintain and provide input to an adequate audit plan for global, regional and local trials, systems and compliance processes
- Manage qualified service providers for GQA, e.g., contract auditors
- Manage audits and contract auditors in line with the audit plan, Kyowa Kirin’s business model and applicable procedures
- Develop, and mentor junior PV audit team
- Ensure that a comprehensive PV Quality System is developed, in place and adhered to
- Ensure continuous improvement and enhancement of the PV Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
- Collaborate with the respective Functional Area Heads
- Collaborate with the respective Global and Regional Quality Leads and functions
- Foster a continuous improvement mentality within Kyowa Kirin
- Ensure the establishment and maintenance of the required Quality Documentation
- Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution
- Manage deviations reported by the Functional Areas and support them with resolution
- Support inspections and health authority inspection management
- Support the preparation for GVP inspections
- Support the responses to Regulatory Authorities
- Support and provide input to the corrective and preventive actions
Qualifications:
- Degree in natural science or equivalent number of years’ experience
- Qualified auditor; Experience of Quality Management Auditing for Pharmacovigilance
- Clinical/industry/Regulatory Authority or otherwise relevant experience,
- Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, and Regulatory Affairs
-
Quality Assurance Manager
hace 1 semana
Madrid, España Simplekyc A tiempo completoSimple KYC is a fast-growing Australian startup working with banks to develop innovate technology solutions that help them automate 'Know Your Customer', 'Anti Money Laundering', 'Due Diligence' and 'Customer Onboarding' processes. We make data easy to visualize, analyze and interact with. We work with industry-leading clients such as American Express, ANZ,...
-
Quality Assurance Manager, Cea
hace 3 semanas
Madrid, España Sdi Digital Group A tiempo completoJob Overview Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and / or global level. Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and...
-
Training and Quality Assurance Lead
hace 4 semanas
Madrid, España Everest Re Group, Ltd. A tiempo completoTitle: Training and Quality Assurance Lead Company: Everest Insurance (Ireland) Spain Job Category: Operations **Job Description**: - Company Overview: Join a leading insurance company dedicated to excellence and innovation in the financial services industry. We pride ourselves on delivering exceptional customer service and maintaining the highest...
-
Quality Assurance Engineer
hace 4 semanas
Madrid, España Accedo Tv A tiempo completoThe multi-screen streaming video and the interactive TV space is growing rapidly. Accedo delivers rich media apps on multiple platforms ranging from Smart TVs, gaming consoles, Set Top Boxes, Roku, Apple TV, Android TV, Chromecast, Web, Smart phones, tablets and more. Accedo is a leading company in this sector and is hiring at multiple locations (Madrid,...
-
Quality Assurance Officer
hace 6 días
Madrid, España PrimeVigilance A tiempo completoCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory...
-
Product Assurance Manager
hace 4 semanas
Tres Cantos, Madrid provincia, España Airbus A tiempo completoIn the framework of Airbus Crisa equipment product development (satellites and launchers), the PA manager will be responsible for: - Ensuring the quality function of different electronic processes (conception, integration, programming, tests, etc.). - Helping the project team which you are part of to succeed, - Guaranteeing that customer needs are met, -...
-
Senior Quality Assurance Engineer
hace 4 semanas
Madrid, España Swiss RE A tiempo completoJoin a team of cybersecurity professionals and help Swiss Re to fulfil its mission in making the world more resilient. As the Senior Quality Assurance Engineer, you'll be tasked with designing and implementing QA practices covering strategy, automation and execution, non-functional testing, and contributing to making the solution end-to-end successful as...
-
Clinical Trials Quality Assurance Manager
hace 3 semanas
Madrid, España Sdi Digital Group A tiempo completoJob Overview Review & approve investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans and track till closure for medium / high-risk / complex quality events arising from Quality Issues, Audits, Inspections or during similar QA activities. Perform Quality Event management within QA-CAPA Center Of...
-
Quality Assurance Manager
hace 7 días
Madrid, España Page Personnel España A tiempo completoComo responsable de Calidad te encargarás de todas las funciones y requisitos relacionados con la calidad para España: - Actuarás como contacto principal en España para temas de control de calidad relacionados con distribuidores y organismos externos y autoridades sanitarias. - Te responsabilizarás de garantizar la calidad e integridad de los...
-
Quality Manager
hace 1 semana
Madrid, Madrid, España IQVIA A tiempo completoJob OverviewThis role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the...
-
Quality Assurance Engineer
hace 4 semanas
Madrid, España Amazon Spain Services, S.L.U. A tiempo completo4+ years of quality assurance engineering experience - Experience in automation testing - Experience in manual testing - Experience as QA lead on medium to large sized projects You'll join a dynamic team, with strong ownership of what we develop and passion to provide a great customer experience. The team will hold you to the highest standards, as we all...
-
Senior Quality Engineer
hace 2 semanas
Madrid, España Oliver Bernard A tiempo completo**Senior Quality Engineer - Gaming and Gambling - JavaScript, Cypress, **Protractor** **Oliver Bernard are currently working with an industry leading Gaming and Gambling company, based in Madrid, who are seeking a Senior Quality Engineer as they look to scale their Automation practices in line with a growing Platform (which operates at a Global...
-
Senior Quality Engineer
hace 4 semanas
Madrid, España Oliver Bernard A tiempo completo**Senior Quality Engineer - Gaming and Gambling - JavaScript, Cypress, **Protractor** **Oliver Bernard are currently working with an industry leading Gaming and Gambling company, based in Madrid, who are seeking a Senior Quality Engineer as they look to scale their Automation practices in line with a growing Platform (which operates at a Global...
-
Quality Manager
hace 1 semana
Madrid, España IQVIA A tiempo completoJob Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the...
-
Madrid, España Lilly A tiempo completoWe’re looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring...
-
Junior Quality Assurance Associate-release
hace 4 semanas
Madrid, España NonStop Consulting A tiempo completoTengo una vacante en Quality Assurance-batch release para una empresa farmaceutica. Se trata del puesto perfecto para aquellos que ya tenéis algo de experiência y queréis trabajar en una empresa llena de gente joven y con un muy buen ambiente laboral y en la cual intentan promocionaros desde el primer dia. Ademas el proceso de seleccion es muy...
-
Project Safety Assurance Manager
hace 1 semana
Madrid, España ALSTOM A tiempo completoReq ID:411000 Leading societies to a low carbon future, Alstom develops and markets mobility solutions that provide the sustainable foundations for the future of transportation. Our product portfolio ranges from high-speed trains, metros, monorail, and trams to integrated systems, customised services, infrastructure, signalling and digital mobility...
-
Senior SW QA Engineer
hace 3 semanas
Madrid, España Ericsson A tiempo completoDescription About this opportunity We are looking for Senior System Testers, passionate about quality and using groundbreaking technologies, to be part of a team made up of the best and brightest engineers in the industry, working in the development of the 5G Packet Core. You will work in a cross-functional team developing new functionalities for...
-
Materials and Processes Quality Assurance
hace 4 días
Tres Cantos, Madrid provincia, España Airbus A tiempo completoSupport to the project Product Assurance Manager: - For M&P topics related to electronic assemblies taking part when needed to customer reviews like: Preliminary Design Review (PDR), Critical Design Review (CDR), Equipment Qualification Status Review (EQSR) or Manufacturing Readiness Review (MRR) - EAQA is responsible for the Materials and Process Control...
-
Quality Manager
hace 4 semanas
Madrid, España Criteria Recursos Humanos A tiempo completoAt Criteria Human Resources, we specialize in providing solutions to enhance the human capital of our client companies, understanding their needs and helping them to make the most of their capabilities. We are a group of committed professionals who work with enthusiasm every day. We make the objectives of our client companies our own and we strive with...