Product Quality Lead

hace 10 horas


Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

Job Description SummaryThe Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.Job DescriptionMajor accountabilities:Accountable for end-to-end quality stewardship (DS and DP) of assigned Novartis biologics product(s) (NBE's and biosimilars) from late phase development to discontinuation.Accountable for the end-to-end product quality strategy (DS and DP) across the global network and drive continual improvement through product and process lifecycle management, represent QBT&A in cross-functional project life cycle team.Provide expert quality guidance, technical support and quality leadership for implementation of quality guidelines, regulations, standards, processes, and strategy for assigned product(s) throughout the product and process lifecycle.Maintain global Quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned Novartis biologics product(s) (NBE's and biosimilars).Act as global quality lead in product related Q escalations, recalls and BPDR handling for product specific quality and compliance challenges.
Provide clear direction and drive efficient decision making for global Quality issues related to assigned products.Involved in major product relevant investigations, in particular multi-sites deviations and recurring deviations, by leading / supporting global investigations / Task Force at the sites.Support global site readiness for product pre-approval inspections across the BT&A platform / network.Bridge between clinical, development and technical operation teams and engages at multiple interface(s) between the organizations to functionally lead and drive robust execution of the defined Product related Quality Program.Actively drive platform wide Q strategy harmonization and promote product Quality as competitive advantage.Minimum Requirements:Work Experience:5+ years of experience in an operational GxP area in a Manufacturing/Development or Quality; Solid knowledge in biology/chemistry, pharmacy and biotechnology, medical devices/combination products; Thorough knowledge and expertise in cGMP and applicable guidelines.Sound scientific, technical and regulatory knowledge, ideally in Biotechnology; expertise in validation(process and cleaning) a plus; Excellent and proven ability to analyze and evaluate cGMP compliance; Proven ability to influence people and communicate in a process-oriented organization; Fluent English, written and spoken.
Any additional language is a plus.#J-18808-Ljbffr



  • Barcelona, España Ares Consultores A tiempo completo

    SummaryThe Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.About the RoleMajor...

  • Product Quality Lead |

    hace 5 minutos


    Barcelona, España Ares Consultores A tiempo completo

    Summary The Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.About the Role Major...


  • Barcelona, España Ares Consultores A tiempo completo

    .This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.SummaryThe Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products)...


  • Barcelona, España Ares Consultores A tiempo completo

    .This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Summary The Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products)...


  • Barcelona, España Ares Consultores A tiempo completo

    The Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advanced Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.About the RoleMajor...


  • Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

    Job Description SummaryThe Product Quality Lead is responsible for the holistic product quality stewardship of assigned Novartis biologics (NBE) and ATMP (Advance Therapy Medicinal Products) across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation.Job...

  • Quality Assistance Lead

    hace 10 horas


    Barcelona, España Wallapop A tiempo completo

    Wallapop is a Barcelona based scale-up driven by the purpose to empower people to embrace a more conscious and human way of consumption. We believe in a world where collaborative economy is mainstream. This is what drives us. Wallapop operates in Spain, Italy and Portugal, offering a catalogue of several hundreds of millions of products and services....

  • Quality Assurance Lead

    hace 2 días


    Barcelona, España Esperanto.ai A tiempo completo

    We are looking for an experienced Software Quality Assurance and Testing technical lead that can design, write and execute a test plan for a Machine Learning compiler for an AI hardware accelerator. As part of our team, you will interact with a broad number of Compiler, System Software, and Performance engineers, as well as a number of RTL designers and...


  • Barcelona, España GE Renewable Energy A tiempo completo

    **Job Description Summary**: The Lead Supplier Quality Engineer - Renewables - Offshore Wind will work closely with Offshore Wind Sourcing, Design Engineering, Product Service Engineering, Manufacturing, Project Management and Installation team, and the Global Supplier Quality team on all activity required to effectively support supplier quality requirements...

  • Quality Assurance Lead

    hace 9 horas


    Barcelona, España Ohtic A tiempo completo

    At OHTIC , our mission is to deliver software development services that span the simplest applications to the most complex challenges.Our clients represent diverse sectors—aviation, automotive, retail, audiovisual, industry, and more.In short, YOU WON'T GET BORED WITH US!Join a dynamic environment where innovation is encouraged, and no two days are...

  • Quality Assurance Lead

    hace 4 días


    Barcelona, España buscojobs España A tiempo completo

    Are you based in the United States? Select your country to see jobs specific to your location. At OHTIC , our mission is to deliver software development services that span the simplest applications to the most complex challenges. Our clients represent diverse sectors—aviation, automotive, retail, audiovisual, industry, and more. In short, YOU WON’T GET...

  • Quality Assurance Lead

    hace 7 horas


    Barcelona, España Ohtic A tiempo completo

    At OHTIC , our mission is to deliver software development services that span the simplest applications to the most complex challenges. Our clients represent diverse sectors—aviation, automotive, retail, audiovisual, industry, and more. In short, YOU WON’T GET BORED WITH US! Join a dynamic environment where innovation is encouraged, and no two days are...

  • Product Quality Engineer

    hace 14 horas


    Barcelona, España Capgemini Engineering A tiempo completo

    En Capgemini Engineering estamos creciendo, y desde nuestra industria de Mecánica queremos incroporar perfiles como tú.Pensamos en alguien con experiência como Product Quality Engineer para trabajar en uno de nuestros proyectos del sector automoción que está ubicado en Viladecavalls (Barcelona).**Funciones y proyecto**:- Ensure, together with the...

  • Product Quality Engineer

    hace 14 horas


    Barcelona, España Capgemini Engineering A tiempo completo

    En Capgemini Engineering estamos creciendo, y desde nuestra industria de Mecánica queremos incroporar perfiles como tú.Pensamos en alguien con experiência como Product Quality Engineer para trabajar en uno de nuestros proyectos del sector automoción que está ubicado en Viladecavalls (Barcelona).**Funciones y proyecto**:- Ensure, together with the...

  • Quality Assurance Lead

    hace 7 días


    Barcelona, España Ohtic A tiempo completo

    At OHTIC, our mission is to deliver software development services that span the simplest applications to the most complex challenges.Our clients represent diverse sectors—aviation, automotive, retail, audiovisual, industry, and more.In short, YOU WON'T GET BORED WITH US!Join a dynamic environment where innovation is encouraged, and no two days are alike.At...


  • Barcelona, Barcelona, España Ohtic A tiempo completo

    About UsOHTIC delivers software development services across diverse sectors, from aviation to retail. We foster innovation and collaboration, ensuring our clients receive top-notch solutions.The RoleWe seek a highly skilled QA Lead to ensure the quality and reliability of applications across critical business areas. As a QA Lead, you will be responsible for...


  • Barcelona, España buscojobs España A tiempo completo

    (EF616) Product Quality Engineer - Automotive Barcelona EUR 50.000 - 70.000 From the automotive industry in Capgemini, we are looking for a profile like yours: with experience as a product quality engineer. The main role is to ensure, together with the Master in Product Engineering, the technical viability of the product during the offer and development...


  • Barcelona, España buscojobs España A tiempo completo

    (A929) | Product Quality Engineer (English & French) Location: Barcelona Salary: EUR 50.000 - 70.000 Responsibilities: Ensure, together with the Product Engineering Master, the technical feasibility of the product during the offer and development stages. Carry out the design reviews under the supervision of the Master in Design. Analyze the results of the...


  • Barcelona, España buscojobs España A tiempo completo

    Y400 - Product Quality Engineer (English & Italian) Location: Barcelona Salary: EUR 50.000 - 70.000 Responsibilities: Ensure, together with the Product Engineering Master, the technical feasibility of the product during the offer and development stages. Carry out the design reviews under the supervision of the Master in Design. Analyze the results of the...


  • Barcelona, España Ohtic A tiempo completo

    At OHTIC, our mission is to deliver software development services that span the simplest applications to the most complex challenges.Our clients represent diverse sectors—aviation, automotive, retail, audiovisual, industry, and more.In short, YOU WON'T GET BORED WITH US!Join a dynamic environment where innovation is encouraged, and no two days are alike.At...