Product Quality Lead |

hace 2 días


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 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, representing 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.Why Novartis?Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.#J-18808-Ljbffr


  • Product Quality Lead

    hace 2 días


    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...

  • Product Quality Lead |

    hace 2 días


    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...

  • Product Quality Lead

    hace 9 horas


    Barcelona, España Novartis A tiempo completo

    6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. - The Product Quality Lead is responsible for the holistic product quality stewardship of...

  • Product Quality Lead |

    hace 2 días


    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 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

    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

    .12 Dec | ES06 (FCRS = ES006) Novartis Farmacéutica | Barcelona Major 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...


  • 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 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 accountabilities:...


  • 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 Role Major accountabilities:...


  • 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 Role Major accountabilities:...


  • 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...


  • 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 4 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 2 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...

  • Quality Assurance Lead

    hace 6 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 2 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...


  • 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...